The NY Times editorial board published an opinion on the price of the new hep C drug yesterday which is very enlightening, but unfortunately it isn't open for comments. http://www.nytimes.com/...
Sovaldi costs $84,000 for a standard 12 week course, or $1000 per pill. Some patients require a course that is twice as long, costing $168K. It is not a stand-alone. This drug is taken combined with the standard pills and injections treatment that has been the standard therapy. This combination can achieve a 90% cure rate, an improvement over other recent drugs in this category that have up to 75% cure rate and that cost $25K to $50K per course. Apparently hep C figures into 15,000 deaths per year. About 3-4 million Americans are infected with the virus, and most don't even know it. Symptoms, if they ever occur, don't appear for two to three decades. In other countries a six month course is being marketed at $2,000. That's how much more Americans pay $168K vs $2K.
Clearly this drug is an advance in treatment, a wonderful thing, but we need to have a look at how our society is going to deal with these costs, and rules governing Pharma. We need to keep an eye on their shenanigans and price fixing and their iron grip on all our legislators on both sides of the aisle as well as the White House. And we also need to draw attention to the TPP, that transpacific trade pact, that has all kinds of protections for Pharma, invalidating laxer patent laws in other countries, shutting down production in countries that are making drugs to save lives, raising prices in other countries rather than bringing down the prices charged to us. For my 13 suggestions to address drug prices see below.
The maker Gilead says that in the long run this hep C drug could save money that would be spent on treatment for liver failure, etc. This estimate has been contested by experts. It is estimated it could add $17B to the state of California's healthcare bill just this next year. The editorial muses about what to do such as give it only to people with advanced disease or getting Medicaid to negotiate the price, since there are other promising treatments in the pipeline, which should offer competition.
This is just one of dozens of examples of new and existing drugs under patent, where the prices demanded simply take the breath away. It's time to rethink this.
Several points follow, and I am no expert on this, but....
1. Do not ratify the TPP.
2. There just are no head-to-head trials with other effective treatments. We need this info. The FDA could require them. Then we can really see if the touted effectiveness rates are what they say they are.
3. Much of initial research for many of these drugs is at universities at taxpayer expense. We need to find a better way to make sure that if the taxpayers have contributed to any stage of development that they have royalties in the sale of the final product. Stop giving biological drug companies special tax breaks like Hatch, Baucus and McConnell did in January 2013 unless they agree to a maximum profit margin.
4. Other countries cap % profits on drugs evidently (I don't know much about this but Steven Brill alludes to this in his landmark article "The Bitter Pill" in one of last year's Time magazines. ) After all, the ACA caps the profits of insurers to 15%, a morally reasonable thing to do because this is people's lives after all.
5. Do not accept unquestioningly that it costs $1B to develop each new drug, and that many fail so high profits are justified. Do not be disarmed by that. Show us research on money spent on those failed drugs. If this is true, why do drug companies spend 35% of their budget on marketing and a much smaller percent on research and development?
6. There needs to be careful investigation of companies for collusion. Why is it that when there is a spate of new drugs, such as for multiple sclerosis, chronic lymphocytic leukemia, rheumatoid arthritis, etc, there doesn't seem to be any competition at all in prices? The prices of the whole field of drugs for a given disease instead skyrockets faster than college tuition. The same company often develops or buys a competitive drug, keeping it under one roof and over a certain price. For example Biogen-Idec owns both of the MS drugs, Tecfidera and Tysabri.
7. Limit the shenanigans. The drug company can give tax deductible charitable contributions to the association of the disease in question, which then helps patients pay more for the drug they are selling. That's double dipping! (By the way did you know that doctors can't write off free care but hospitals and drug companies can?) Drug companies keep a physically tight control of each dose, especially injectable drugs, so that generic companies can't get their hands on it to begin to develop the generic. Companies have been known to pay generic companies to delay the generic drug's introduction to the market.
8. Encourage medical specialty societies to include in their recommended treatments the relative cost, keeping in mind that "financial toxicity" of a treatment is a very real concern.
9. Encourage the FDA to speed up examination of alternative treatments and drugs when existing treatments are shockingly priced. For example why are there no more progesterone-coated IUDs being approved? Some years back the price of Mirena doubled overnight for no obvious reason. It is over $1000 now with the insertion. Finally a second one came on the market, guess what, it is owned by the maker of the first one, Bayer. So no break in price. Now patients who use the prog IUD get it for free if being used for contraception but that's not the only use. So if they've had a tubal and need it, it goes to the deductible. And society is paying a back breaking amount for the ones that are being used for contraception. (It's still cheaper than pregnancy and very effective, but still, if there were competition, we would save billions.)
10. Consider allowing the government to partner in phase 3 clinical trials for drugs that are promising for a new indication, but which don't offer a huge profit potential because they are off patent or about to be off patent. For example Rituxan for MS.
11. Medicaid requires rebates from drug companies. Medicare does not. By all means let Medicare negotiate drug prices or else require rebates as is in the bill by Sen Jay Rockefeller (D-WV), the Medicare Drug Savings Act. This act restores rebates for people who dually eligible for Medicare and Medicaid and imposes them for low income Medicare patients. The NYTimes editorial suggests state Medicaid agencies negotiate with Gilead on the pricing of the hep C drug or "find other options to limit the drug's use when other good options are available".
12. Stop this ridiculous TV advertising of drugs. At least until they've been on the market 10 years with strong post market safety data. It didn't used to be allowed and that was a good thing.
13. Allow some importation of drugs if they are made in countries with a stringent inspection system- not just Canada. More of Canada's drugs are coming from abroad. The ironic thing is that Pharma itself makes many its drugs abroad, including in China (!), and the FDA is just now going over there to step up inspections? If there was one place I would not want my drug to come from it's China. And we though all our drugs are made safely right here at home.