The High Cost of Harvoni; Luck was on My Side

When Gilead first announced that they were going to charge $84,000 for a twelve week course of treatment of Harvoni in the USA, it caused quite an uproar. It was shown to have a 90+% cure rate and relatively low side effects so, of course, huge numbers of people with Hep C were going to want to be treated. But at that price, the highest price they charged for the drug anywhere in the world, most people felt they were gouging the sick (and their insurance companies). Gilead trotted out all the usual arguments about the cost of developing the drug, the need for the drug (or any drug) to be profitable in order for them to have a reason to manufacture it and the fact that many countries capped the price they were able to charge, but people in the Hep C community in the USA mostly felt that the price was unreasonably high. After all, if you only treat 100,000 of the conservatively estimated 5,000,000 people with Hep C in the USA at $84,000 per treatment, you rack up $8,400,000,000 in gross sales. That seems be a number that, along with sales in the rest of the world, is going to be giving Gilead a fairly massive profit.

Aside from the sheer cost of the drug to health care providers, the hammer really falls on the people actually infected with Hep C. If you don't have insurance, you are basically screwed. If you have one of the bronze level plans of the Affordable Care Act with a 40% effective co-payment you would have to pay $33,600 for treatment. A silver level plan would leave you with a $25,200 cost and even a gold level plan would still run you a bit over $16,000 out of pocket to be cured of Hep C. For those of us in the fast disappearing middle class in the USA, these are fairly staggering amounts. Sure there are various subsidies and cost breaks available, but given the way they are structured, if you make an amount of money that puts you in the middle class, you are often ineligible for help. I could get into a long rant here about how the Affordable Care Act is really only an affordable insurance act and the cost of any serious health care is just as out of reach under Obama's sellout to the insurance industry as it was in the days before the law was passed, but I will spare you that diatribe. Suffice it to say that the combination of Gilead's predatory pricing and Obamacare's mostly high patient payments means that a large number of Hep C sufferer's are shut out of access to the latest and best treatments available.

Earlier this year, Gilead announced that it will be cutting the cost of Harvoni by 46% sometime this year. This is because AbbVie has introduced their own interferon-free treatment Viekira Pak (which is priced similarly to Harvoni). While this competition is a good thing, the fact that the AbbVie product requires 4-6 pills a day and has more side effects than the single pill Harvoni might mean that it does not provide an effective competitor. If the competition is effective and does induce a lower cost for Harvoni, it means that treatment under a bronze plan would cost about $18,000; a silver would be $13,000 and a gold plan would drop to just over $8,000. While much better for patients, these are still large numbers. Numbers that would have put the treatment out of reach for someone like me.

I got lucky. I have health insurance through my employer and the roll-out for Obamacare has been complex enough that many employers have been granted waivers the past few years allowing them to keep their former plans in place until the regulations for employer-paid Obamacare plans have been worked out. My employer was granted that kind of waiver. I am insured by Kaiser Permanente in San Francisco and my plan is one that has a $30 co-pay for prescription drugs. I have been closely watching the Kaiser drug formulary (the list of which drugs Kaiser provides through their plan) to see when and if Harvoni was added. As soon as it was, I contacted my gastroenterologist to try to initiate treatment. Luckily for me, Kaiser has an extremely proactive view toward Hep C treatment. They believe that everyone who wants to receive treatment should have access. They seem to understand that, regardless of the high cost of the medication, it is cheaper to treat than to deny treatment and then have to pay the higher costs of late stage Hep C and/or cirrhosis treatment. Many insurers are not as forward thinking. Kaiser did initially prioritize the Harvoni treatment to the sickest patients but as that cohort moved through treatment, they rapidly expanded care to their other Hep C patients.

When I saw my gastro guy, I explained that I currently had a health plan that made treatment affordable, but that our current plan would be most likely transitioning to the less affordable Obamacare varieties by the end of the year and thus I would like to be treated as soon as possible. He told me stories of a number of his patients on the lesser insurance plans who indeed were currently shut out of treatment. This factor meant that while my liver is not in a particularly bad state, he agreed that the issue of affordability was one that qualified me for moving up the queue for treatment. He set up the necessary tests and within a month, I began treatment.

I feel extremely lucky that the new drugs came out when they did, that Kaiser moved relatively quickly to include them in their formulary and that they have a very proactive institutional policy toward treatment.  If any of these factors had taken another 6 months to work out, most likely I would be like many other Hep C sufferers on the outside of treatment looking in.

New Drugs, New Treatments, New Hype

In mid-June of this year while at a baseball game watching my childhood hometown Minnesota Twins defeat my adopted home town team San Francisco Giants, a friend asked if I was excited about the news in the paper that morning about the new cure for Hepatitis C. He said that it cured 80% of all patients in clinical trials and that the treatment might last only 24 weeks instead of the standard 48 week therapy. The news was stunning. Which drug was it? I had been keeping up with the various new drugs in the FDA approval pipeline and had never heard of one with a viral clearance rate of more than 65%. Of course he couldn’t remember the name and none of us had a smart phone with us, so it took until after game and back at home before I could do any research.

This article appeared in the San Francisco Chronicle. It stated that about 80% of HEP C patients “with the most common strain” and relapsers from previous treatment were cured by the new drug. The drug was the protease inhibitor telaprevir, brand named Incivek by its developer Vertex Pharmaceuticals. Imagine the amount of money they must have paid a naming company to develop that brand name; rolls right off the tongue. The results from earlier studies had indicated that telaprevir increased the Sustained Viral Response (SVR) in genotype 1 HEP C, the most common genotype infecting US residents, to 65%. It seemed prudent to search out the source material to sort out all these percentages. A quick search of the web found this press release. In the fourth paragraph of the release it stated that “The sustained virologic response for patients treated with Incivek across all studies, and across all patient groups, was between 20 and 45 percent higher than current standard of care.” This seems to indicate that the low end of the SVR rate was indeed 65% and the high end might be almost 90%. The article and press release also indicated that 60% of treatment naïve patients achieved a rapid viral response (RVR) in 4 weeks and these folks not only would only be in treatment for 24 weeks, but had a 90% chance of achieving an SVR as well. It is not clear what the SVR rate for the folks who don’t achieve a RVR and continue for 48 weeks of treatment has been in the tests. It is also unclear whether there is a difference in SVR rates between genotype 1a and 1b. Folks who had relapsed after previous treatments had a 32% SVR rate when treated with the telaprevir, interferon and Ribavirin cocktail. This is very good news indeed for HEP C patients.

A month earlier, this article appeared in the NY Times announcing the debut of Victrelis the brand name of boceprevir (again where do these brand names come from) another protease inhibitor, this one developed by Merck. This drug, which is taken for either 24 or 48 weeks in combination with interferon and Ribavirin, has an SVR rate for treatment naïve genotype 1 HEP C patients of 65-70%. The SVR rate for patients who relapsed after previous treatment is about 40%. Boceprevir is a bit different in that the patient starts with 4 weeks of standard treatment and then adds the boceprevir for either an additional 24 or 48 weeks depending on the viral response. So we have two competing drugs available whose addition to the standard of care treatment increases the SVR rate by a range of 20 to 40 percent. Good news indeed but what is the rest of the story.

The rest of the story has several chapters from side effects to cost of treatment. Looking at side effects first, both boceprevir (Victrelis) and telaprevir (Incivek) have additional side effects to add to those caused by interferon and Ribavirin and both can somewhat intensify the interferon and Ribavirin side effects as well.

Boceprevir can increase the risk of anemia and neutropenia, cause strange taste sensations and cause intestinal tract issues.
Telaprevir also increases the risk of anemia, causes diarrhea, and most importantly can cause an itchy rash. The rash can be serious enough to require that the patient stop taking the telaprevir.

The new drugs are very much like the established treatment in that those with lower viral loads at the beginning of treatment have a better chance of success than those with high viral loads. Also like the established treatments, anyone who has ever tried a treatment, whether standard or experimental, and failed also has a considerably lower chance of success.

Both drugs are protease inhibitors. This means that they inhibit the action of an enzyme that the virus needs to reproduce. They are similar to the protease inhibitors developed to fight the AIDS virus. This means that they must be taken on a fairly rigid schedule: three pills per day, one every eight hours. If that means waking up to take it, wake up you must. They also need to be taken with food, so you cannot pop a pill and run off. You have to have certain types of food with the dose of the drug. This means that for 12 weeks (telaprevir) or 24-48 weeks (boceprevir) your life will be scheduled around your drug dosing.

Both drugs are vastly expensive as discussed in this article. Boceprevir/Victrelis will cost $1,100 per week making the cost of a full course of the drug either $26,400 (24 weeks) or $52,800 (48 weeks) depending on your viral response. Telaprevir/Incivek has been priced at $49,000 for the 12 week course of treatment. This cost is in addition to the $15,000-$20,000 (24 weeks) or $30,000-$40,000 (48 weeks) for the interferon and Ribavirin with which they must be taken. This also does not count the cost of the Procrit to fight anemia ($500 per week) or the Neupogen to fight neutropenia (also about $500 per week) should you need them. There are also the costs involved with antidepressants, sleep medications, thyroid medications, pain medications and whatever you will be using to deal with the rash and itching in the case of the telaprevir.

It is also not clear how quickly insurance plans will add them to their drug formularies. Kaiser Permanente, my HMO here in California, has added both to its formulary. I do not know which other insurance providers have done the same. Even if they are added, it is not clear what the requirements will be for a patient to be eligible to be prescribed and how easily insurance companies will make them available. From an economic point of view they should make them easy to get as even at these prices the cost of treatment is still much less than the cost of a liver transplant.
For those without insurance, I do not know how anyone but the wealthy could afford the additional cost. The cost of standard of care treatment is by itself so high as to exclude many HEP C sufferers from being treated. There are programs to assist those with low resources to get treatment but even with the drugs deeply discounted the ability to come up with as much as $20,000 for a course of treatment would seem impossible.

Despite all these potential problems, the advent of new drugs to combat HEP C is excellent news. Ramping up the SVR rate to a range of 60% - 80% is a vast improvement over the standard of care treatment rate that topped out at 45%. Psychologically, it is far more encouraging to go into a course of treatment thinking you have a 2-1 shot at beating the virus than to go in thinking you have just under a 50-50 shot. These drugs are also only the leading edge of a wave of new drugs and new therapy approaches that are under research and testing. There are new polymerase inhibitor drugs that have SVR rates similar to telaprevir, but with fewer and less severe side effects. Testing on the holy grail of finding a treatment regimen that does not have to include interferon is also underway with early stage results coming in soon. Within the past year, scientists have discovered a method of growing the HEP C virus in the lab. This means that future early stage testing of drugs can be done directly on the virus instead of with animal models. This should increase the pace of research dramatically. In all it is a good time to have HEP C if you are one of us infected. There are established treatments, there are promising new treatments and there are drugs and treatments in the research and development pipeline that seem to point to future in which HEP C can be attacked and treated with a high expectation that it will be successfully cleared from the human body.

Perhaps we can believe the hype surrounding these new drugs. Despite the problems of determining the actual efficacy of the drug in your own case, the potential difficulties in obtaining and paying for the treatment and persevering through the side effects, they have advanced the cause of combatting Hepatitis C.

The more cures, the fewer pig livers will have to be implanted in humans (sorry, I’ve been reading far too many science fiction novels during treatment).

Money Saved Is Money Earned

In one of the last posts I did before I lost the energy to continue writing, I talked about the differences in care between a centrally administered health care organization (in my case the Kaiser HMO) and a health insurance model of care. One of the biggest differences is in the way drug prescriptions are handled. While under health insurance, the copayment for commonly prescribed drugs and drugs with generic equivalents was $15 for each prescription. Uncommon drugs or drugs whose patent had not yet run out or there were no generic equivalents available had much higher copayments depending on which supply store or agency you used. In the case of HEP C, the high-copayment drugs needed for treatment were Interferon (Pegasys), Procrit and Neupogen. My copayment for each of these was $100 for a 4 week supply. These drugs had to be ordered many days in advance from an out of state specialty pharmacy that delivered them via express mail. When you added in Ribavirin, the thyroid meds, the Ambien for sleep, Celexa for depression and the Vicodin for the weekly bought of muscle pain, the copayments added up to $375 every 4 weeks. During the 7 months of Standard of Care treatment while covered by health insurance the grand total was roughly $2800 in copayments for the meds.

Under the Kaiser HMO model of care, it is very different both in cost and the ease of getting the necessary meds. Kaiser has all the drugs available through their pharmacy. The is no longer any need for ordering interferon, Ribavirin, Procrit and Neupogen through an out of state mail order pharmacy; a pharmacy that had to send the stuff in an insulated carton with freeze packs and once mistakenly sent the meds to Canada. It can now be picked up at the local Kaiser pharmacy without the necessity for ordering many days in advance to make sure all the necessary approvals are in order. Kaiser also considers a standard order to be larger for some of the drugs than do the health insurance people which means there is more bang for the buck. The copay for the Ribavirin, Celexa, thyroid meds, Ambien and vicodin are still $15 but the prescriptions are for greater numbers of pills each. The interferon, Procrit and Neupogen all have a $25 copayment. In the case of the interferon and Procrit it covers a 4 week supply, for the Neupogen it covers an 8 week supply. Thus a 4 week supply of the necessary meds adds up to about $120. The savings amount to about $1500 for the length of treatment done while at Kaiser. This is not a trivial amount for the folks in my pay grade.

There are a lot of other differences large and small, good and bad, between the two methods of supplying health care and I hope to go into them more in the near future. This difference however, is nothing but good. $1500 saved covers a full month of expenses in my world and that is the same as $1500 earned.

Health Care versus Health Insurance

When last I wrote, I was just about to institute a change from the good people at California Pacific Medical Center (CPMC) through Blue Shield insurance to the Kaiser Permanente Health Maintenance Organization. Our organization changed its insurance policies and the only affordable option was to go with the Kaiser HMO. From my first appointment with my new Primary Care Physician (PCP) it was clear that Kaiser’s approach is very different from standard insurance. It is the difference between a Health Care Organization and a Health Insurance Organization.

I made an appointment to see my new PCP - which appointment I was able to get for only two days after I called. I picked my new doctor from a roster of available doctors because she had been working in the Chinese community on some Hepatitis B projects and thus was already familiar with Hepatitis cases. When I went in to see my PCP, I brought along my lab reports and health summary updates from my doctors at CPMC. I gave her my data and she began asking questions and typing lots of information into my medical record via the computer in the examining room. My biggest single concern was making sure that my meds, which were running low, would be able to be continued and that I would not miss doses in my treatment regimen. She started entering in my various medication and doses, checking instantly to see if the same drugs were available and in stock at the pharmacy. On her own authority she was able to prescribe all my meds and send the prescriptions through to the pharmacy via computer. This included pegasys and ribavirin as well as the thyroid medicine, the antidepressant and the sleep aids. You could have knocked me over with a feather. She then forwarded my records over to the gastrointestinal department and told me that someone would be calling me that afternoon to go over my information and set up an appointment. She also made instant referrals to the psych department to set up a neuropsych evaluation as per Dr. Bzowej’s recommendation and to some various other departments to handle some other health issues unrelated to the Hep C. This all happened in a 40 minute appointment in which, despite her working at top speed – especially in data entry, never felt rushed. She then gave me her card with email and phone contact info and told me to call her with any further questions. I walked out of the appointment in shock.

Compare that to what Blue Cross (or Blue Shield, Healthnet, Aetna – I’ve had them all over the years) would have done. I would have seen my PCP. They would have had to write a referral to a Hepatologist. The referral would have to have been approved. I would have seen the Hepatologist. That doctor would have had to prescribe the meds I need for treatment. The prescriptions would have had to be approved by the insurance company. I would have had to go through a specialty pharmacy to get the meds. I have no idea how long that might have taken even if there was an attempt to expedite the process due to my ongoing condition.

It is all due to the difference in business model that each type of organization has. Kaiser’s model is that I pay a monthly fee for my health care. They make money (they are a non-profit corporation, but they need to at least break even for all this to work) through efficiency and by rationing care. If you are seriously ill they are on the job, if you have a sore throat you had better have had it for a long time before they are going to set you up with a doctor’s appointment. The whole implementation of computerized records and paperless referrals means that they save beaucoup bucks in paperwork costs. They also are proactive with immunizations and diagnostic tests because they are aware that early detection of disease means that treatment is easier and cheaper. They have their problems to be sure, but they offer good care.

The insurance company model is that you pay a monthly fee for insurance against illness. They make money by limiting your care. They do this by making referrals and authorizations for treatment difficult to get. They also are very careful in how much they pay to doctors and hospitals for treatment and frequently deny payment or portions of payment for treatment. They are less likely to emphasize preventive care because that costs money out of pocket and you might never get that particular illness while insured by them. On the other had they offer considerably more flexibility in whom you can see and where you can see them for care.

Going forward will be an interesting journey, but the first experience has been very good and at least I was able to continue uninterrupted treatment.

P.S. The gastroenterologist really did call me back that afternoon and he set up an appointment for only three days later…

More Dread – Heath Insurance Woes

Insurance Plan Change Forces Change Of Doctors

The new year continues its run of good news as I found out that none of the health care options (the ones I can remotely afford anyway) that are available to me under our organization’s new health insurance plans, allow me to continue with the team that has been currently treating my Hepatitis C.

As several of the recent posts have detailed, our organization changed its health insurance broker and plans for the upcoming year. In order to save money (and I can’t really argue with this as the insurance costs for the organization have risen 40% for this year), they subscribed to Blue Cross “Select” and Heathnet “Silver” insurance plans in addition to the standard Kaiser Permanente plans that have been offered for years. While initial and even follow-up research indicated that my doctors were contracted with both Blue Cross and Healthnet the final determination that came through the brokers was that, while they are contracted to both Blue Cross and Healthnet, they are not contracted with the two stripped-down plans that our organization subscribes to. I could subscribe to a PPO that includes my doctors, but the monthly cost would total more that $4,000 per year, plus the $4,800 in yearly drug co-payments, plus very high deductibles on any medical procedures and hospitalizations that might occur and I just can’t afford to pay those kinds of fees on my income here in one of the most expensive cities in America.

On the positive side, I still have health insurance. It will be through Kaiser Permanente and will be funded by my employer. Kaiser does good work and has good doctors. Even the treatment nurse who has been handling my care at California Pacific Medical Center, was hired away by Kaiser and he is top-notch. The only problem is whether I can manage the transfer of my treatment to Kaiser during the relatively small window of time until my prescriptions run out. I have to get a primary care doctor, have him refer me to a hepatologist, have my records transferred and have my meds continued during a time period of about 20 days. I get to find out how much stress and complication I can handle with a Swiss cheese brain and a 30-day supply of anti-depressants. But that’s the modern world we all have to cope with, so the best thing to do is buckle down and dive in, to mix up some metaphors.

There are lots of people in much worse shape than I am. There are folks with the disease and no health insurance who depend on the largesse of drug companies or aid programs. There are people on waiting lists for liver transplants that are watching their window of opportunity close on them. There are people even with health insurance who are paying huge chunks of their income or going into debt to get access to treatment. I am in none of those positions and I appreciate that more than I can say. I would just like to get some good news at the start of the year. Maybe the Giants will trade for a right-handed bat, the Niners will sign a quarterback, or the Warriors will make the play-offs. I can feel my immune system recharging already.

Heprat’s Coverage Is In The Health Insurance Twilight Zone

The following story is sadly not unique to my situation.

The phone call came from the HR director of our organization. He told me that our health insurance broker had called him with the information that my primary care physician (PCP) only had a contract with Anthem Blue Cross (world’s scariest health insurance company) as a specialist, not as a primary care physician. Therefore I would have to find a new PCP. I had been going to my PCP for 12 years through 4 insurance carrier changes. For the entire time he had been affiliated with a physician group that has contracts with every major health insurance company. Something did not smell right about this ruling.

My PCP had written all my referrals to specialists for my Hep C treatment. He had written several of the prescriptions for the drugs to manage my Hep C side effects. If I had to find a new one, the new doctor would have to get up to speed on my condition, reinstitute all my referrals and prescriptions and do it all by the 10th of January when my supply of Ribavirin would start to run out.

Heprat, man of panic and desperation, sprang into action. I called my PCP’s office. They told me in no uncertain terms that they had a PCP contract with Blue Cross as many of their patients had Blue Cross insurance. I went to the Anthem Blue Cross website, searched for PCP physicians within 2 miles of my home and my doctor appeared on their list of Primary Care Physicians. Not only that, but the doctor code for his PCP status was listed and it said that he had an open practice and was currently accepting patients. Armed with this information, I called the insurance broker for our organization. I explained my situation and they repeated that according to the website of the insurance broker they used, my doctor was only contracted as a specialist; they even went online and checked it while we talked. I told them that I was looking at the Blue Cross website and on that site it clearly stated he was a contracted PCP. I reminded them that the broker website they used for their information had been wrong about the Blue Cross drug formulary and wrongly stated that my hepatologist was not a Blue Cross doctor. They grudgingly admitted that the Blue Cross website might be more accurate than their broker website and agreed to resubmit the paperwork with the codes I provided them from Blue Cross. Now we wait on Blue Cross to process the paperwork.

The Ribavirin runs out on the 10th of January. The interferon runs out on the 14th of January. My thyroid medication runs out on the 9th of January. The Celexa runs out on the 17th of January.

I suspect my neighbors think I am either insane or being brutally beaten as I have spent several minutes the past few afternoons walking around the house and screaming. It sounds terrible but it really does help relieve the stress. For all of you out there in this same situation, I recommend screaming. It lets out your feelings and leaves you so damned tired that you don’t have enough energy for an anxiety attack.