September 2, 2011 4:35 pm
This article is provided to FT.com readers by BioPharm Insight—a news service focused on providing insight into the most price sensitive issues in the global pharmaceutical market. www.biopharminsight.com
Vertex Pharmaceuticals’ (NASDAQ: VRTX) Incivek (telaprevir) and Merck’s (NYSE: MRK) Victrelis (boceprevir) are largely being reimbursed by payers, after a prior authorization period of one to four weeks, hepatologists told Biopharm Insight. In some instances, there has been payer pushback with telaprevir due to its higher price, some experts noted.
Both drugs were approved in May, as a treatment for hepatitis C (HCV) in combination with pegylated-interferon and ribavirin.
Telaprevir is currently priced at USD 49,200 for 12 weeks of therapy, while boceprevir is priced at USD 1,100 per week, for a total treatment cost of anywhere between USD 26,400 to USD 48,400 depending on individual patient response to therapy.
Mitchell Davis, DO, medical director at the Hepatitis Treatment Institute of Florida, said there was some outcry from the community on the pricing of these new agents, but both manufacturers have established “aggressive” patient assistance programs.
Vertex’s co-pay assistance covers up to 20% of the total cost of telaprevir for people who pay out-of-pocket or have an insurance co-pay, regardless of household income. If the co-pay is less than the 20% of the prescription price, the drug will be free.
The Vertex Free Medicine Program will provide telaprevir at no cost to people who do not have insurance, are not covered by other benefits programs, and have an annual household income of USD 100,000 or less, according to a company press release.
Merck is offering a discount co-pay card that will allow eligible individuals to save up to USD 200 on up to 12 boceprevir prescriptions for up to 48 weeks, though many people will not need to be treated that long, according to a company press release.
Ultimately, patients don’t care about the total cost, but what their co-pay is, said Dr Paul Pockros, head of the Division of Gastroenterology and Hepatology, Scripps Clinic. Pockros, who has written an estimated 60 prescriptions starting patients on triple therapy, said payers have been reasonable. Dr Melissa Palmer, director of Hepatology at NYU Hepatology Associates, estimated writing nearly 250 prescriptions in total for both drugs, and added she has faced no issues so far with reimbursement.
Dr Doris Strader, associate professor of medicine, Division of Gastroenterology, University of Vermont College of Medicine, estimated a prior authorization period of three to four weeks. Generally, it is slightly longer than the prior authorization period with pegylated-interferon and ribavirin, she noted.
There is a “pretty quick turnaround” from payers with regards to these two new HCV drugs, said Dr Michael Epstein, gastroenterologist and founder of Digestive Disorders Associates in Annapolis, Maryland. He noted that his center often works through specialty benefits pharmacies to take “a lot of the sting” out of the process. Dr Tarek Hassanein, a hepatologist and medical director at Southern California Liver Centers, similarly reported using specialty benefits pharmacies to make the process easier.
A Merck spokesperson said specialty pharmacies have a legacy position in HCV in offering pegylated-interferon and ribavirin, and it is expected they will continue to maintain an important role, with Merck having a long-term strategy to work with that channel.
Having written 20-30 prescriptions for triple therapy, Hassanein said thus far, only two of his patients have been denied coverage. Those payers did not provide clear reasons for denying coverage, he noted. Davis added he has heard from the community that some payers have chosen to cover one drug but not the other -- although it has not happened in his practice.
Pockros noted he has particularly been having difficulty with Blue Cross of California, which is the biggest payer by volume for his practice. This specific insurance company has been requiring a USD 19,000 co-pay for telaprevir. The Vertex patient assistance program covers roughly USD 10,000, and the remaining difference is still too large of a financial burden to patients. This is in stark contrast to some other payers, which require only a USD 50 monthly co-pay.
“We are putting some of these patients on boceprevir, because it costs less,” Pockros said.
The Merck spokesperson said Victrelis has received a preferred or exclusive position in the formularies of some public payers, based first on its safety and efficacy proposition, followed by its dollar value proposition.
Dr Michael DeMicco, a gastroenterologist with Associated Gastroenterology Medical Group in Anaheim, California, said he has encountered some difficulty with other payers based in California, including Medi-Cal and CalOptima.
Multiple letters detailing how sick the patient is have to be sent, along with their likelihood of developing cirrhosis, a common complication in HCV patients, to get the new drugs approved by these payers, DeMicco explained. These payers have been “very resistant,” he added. However, Dr Sammy Saab, associate clinical professor of medicine, Division of Digestive Diseases and the Division of Liver and Pancreas Transplantation at UCLA, said the specialty pharmacies his center works through have noted that Medi-Cal has been the easiest payer to work with.
Payers have been asking for a baseline viral load and checking the genetic basis of a patient’s disease, said Pockros, as both drugs are currently approved for use only in only some HCV patients, who are classified as Genotype 1. Coverage was denied for off-label use in a Genotype 2 patient, he noted.
Epstein said for each patient, he typically provides payers with a clinical evaluation that was conducted within the last month, the patient’s lab results from the last 90 days and a liver biopsy test from within the past year.
Payers largely have not been asking for any interim treatment data, such as week four HCV RNA viral load, which indicates a patient’s response to treatment, several sources noted, though some mentioned having heard this occurring elsewhere. Ethically, “I don’t know how [payers] can wait for that viral load,” said Palmer, as the time lag could result in a patient missing doses while waiting for additional authorization.
Once prior authorization is received, payers have been deferring to clinician judgment on whether to continue therapy or not, said Strader. For telaprevir, with a total duration of treatment of only 12 weeks, some interim lab results might only be returned after the patient completes treatment, she said. With boceprevir, maybe some interim lab data would be returned while still during the course of treatment.
Praise for HCV patient assistance programs
Both companies have been generous about patient support, said Pockros, particularly for patients that fall in the Medicare Part D “donut hole.” Though his center rarely sees Medicare patients, Davis noted that it is difficult for these patients, as they are unable to pre-pay to gain access to these new drugs, unless they have a secondary pharmaceutical plan.
The prior authorization period can take longer when patients have additional financial concerns, Davis added. Some additional financial paperwork has to be done, which is usually a disclosure the patient makes under a income cap, he said. The companies have not been asking for tax returns in these cases, he added.
Pockros discussed a telaprevir patient who had insurance, but then lost his job two weeks into treatment. By the time the patient notified Pockros, he had only three days to get the patient telaprevir so he would not miss a dose, but the patient’s COBRA insurance still had not gone into effect. Pockros said he was able to contact Vertex, and the company was able to ship the drug to the patient, in order to avoid missing any doses.
Palmer reported a scenario for a boceprevir patient, where the specialty pharmacy did not get the drug to the patient in time, but found that Merck was unable to get drug to the patient in this scenario. She said she brought this situation to Merck directly, and that the company is actively working to get a program in place.
The Merck spokesperson said scenarios like these do happen, which are outside of the company’s control, and the usual process by which a patient receives his/her drug. He said Merck has put into place both supply chain and specialty pharmacy initiatives to try to ensure rapid, immediate, and uninterrupted drug supply, but that “there are always going to be those wrinkles” to the usual process.
Both Pockros and Palmer said they typically keep pegylated-interferon and ribavirin on hand for such scenarios, but that there are currently no samples available for either drug, with physicians left to rely on these gap programs instead.
Vertex could not be reached for comment.
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