Gene Goldwasser died last week. He was 88, and he was my friend.
I wrote previously about a series of conversations I conducted with Gene and Rabbi A.J. Wolf a few years ago. I met Gene one spring day after calling to invite him to sit in on a class I was teaching to a small group of medical students about social issues in healthcare.
I’d read about him in a book called “The $800 Million Pill,” by Merrill Goozner. In the book, Goozner writes the story of Gene’s two-decade hunt to isolate the hormone erythropoietin (EPO).
Part of the story relates how Gene tried to interest traditional big pharma companies in his discovery, only to be brushed aside. Instead, Gene wound up sharing his discovery with what became Amgen. The company went on to make a windfall from recombinant production of the hormone and licensing it as a drug for patients with anemia and kidney failure. Read more »
*This blog post was originally published at ACP Internist*
Dan Todd, Senior Manager of Reimbursement for Amgen Pharmaceuticals, recently presented a candid view of how current healthcare reform initiatives may negatively impact his industry. Here are the highlights from the Medicare Policy Summit in Washington, DC:
1. Comparative Effectiveness Research: while the Obama administration’s new emphasis on comparative effectiveness research is not supposed to influence coverage decisions or draw conclusions about “cost effectiveness” – there is no current policy to prevent that from happening. Pharmaceutical companies are nervous about coverage being denied for their products that don’t fare well in head-to-head studies with alternative treatments.
2. Physician Payment Reform: as payment mechanisms move away from fee-for-service and towards episodic care compensation, physicians will no longer be directly influenced by price differences between drugs. Specialist physicians who used to purchase drugs (such as in-office administered chemotherapy agents) under a competitive acquisition program from pharmaceutical companies (and then seek reimbursement from Medicare), will now have less incentive to select one drug over another based on price. Physician compensation will not be dependent on the price difference between drugs – but on the overall bundled services for an episode of care for each patient.
3. The Rise Of Primary Care: as more emphasis is placed on improving compensation to primary care physicians, specialist services will likely receive lower reimbursements to cover the higher payments for PCPs. Since specialists are more likely to prescribe more expensive drugs that have more generous margins (under Medicare Part B), the pharmaceutical industry will be negatively impacted by the improvements in primary care reimbursements for cognitive services.
4. Stifling Innovation: perhaps the most compelling argument made by Mr. Todd is the potential stifling of innovation that a comparative effectiveness regime could impose. Blockbuster drugs are rarely discovered in a vacuum. They are the result of incremental steps in understanding the biology of disease, with an ever improving ability to target the offending pathophysiologic process. The first few therapies may offer marginally improved outcomes, but can lead to discoveries that substantially improve their efficacy. If an early drug is found to be only marginally better than the standard of care, an unfavorable comparative effectiveness rating could kill the drug’s sale. Without sales to recoup the R&D losses and reinvestment in the next generation of the drug, development may cease for financial reasons, and the breakthrough drug that could cure patients would never exist.
5. Timing The Release Of Drugs: Navigating the complexities of Medicare reimbursement, with its separately funded Part B and Part D, is a pharmaceutical company nightmare. With the additional scrutiny on comparative effectiveness and functional equivalency proposed in reform measures – timing of drug releases make a big difference in reimbursement. Take a subcutaneous (SQ) versus an intravenous (IV) version of a given drug for example. The market for the SQ administration is much larger than that of the IV route, but if the drug company releases the SQ version too soon, denial of payment for the more expensive IV version will begin to eat away at profitability. As Dan summarizes, “there’s a fine line between expanding your market and cannibalizing it.”