A PBM is, generally, a third party administrator of prescription drug benefits for private and public insurers (such as state Medicaid programs). A PBM is primarily responsible for processing and paying prescription drug claims. There is complexity in the arrangements between PBMs and insurance plans about which entity makes final decisions related to patient access and how much, in this case, decisions are made based on the price of the medications. Project Inform is working to understand the relationships PBMs have with various insurance plans and to understand how the agreements between manufacturers and PBMs or insurers will impact patients’ ability to access appropriate hepatitis C drugs.
Just three days after the approval of Viekira Pak, the PBM Express Scripts announced an agreement with Abbvie to make Viekira Pak the exclusive drug for patients with hepatitis C genotype 1 and to remove any restrictions to patient access based on severity of disease or provider specialty, in exchange for a reduced price for Viekira Pak. Many PBMs, insurers and public insurers had already restricted access to Sovaldi. The drug was the first hepatitis C drug to come to market that was curative, highly tolerable and of short treatment duration. The restrictions on Sovaldi thus far have limited access to the drug to patients with advanced fibrosis or cirrhosis, and restricted prescribing to specialists, like hepatologists. Many PBMs and insurers argued that the restrictions were necessary — that the high price tag of hepatitis C drugs makes it impossible to treat everyone living with the virus. These restrictions have severely limited access to hepatitis C drugs. The Abbvie-Express Scripts agreement is laudable in that it removes onerous restrictions and promises to increase access to curative therapies. However, the unanswered questions are how this agreement will unfold in practice and how patients for whom Viekira Pak is not clinically appropriate will access other hepatitis C drugs.
Gilead fired back with four agreements: one with the PBM CVS, another with the insurance company Anthem, a third with the insurance company Humana, and a fourth with the insurance company Aetna to provide exclusive or preferred access to Harvoni and Gilead’s previously FDA-approved drug, Sovaldi. To date CVS has not had overall restrictions based on severity of disease or provider type, but as the world of PBMs and insurers is so complicated, further research on the part of advocates will be necessary to uncover and sift through the details. It is thus unclear whether CVS’s previous policy will change now that it has inked an exclusive deal and whether the insurance companies it services will follow suit.
Anthem has stated publicly that it will not remove current restrictions and will continue to limit hepatitis C treatment to patients with advanced liver disease. How the exclusivity agreement between Gilead and Humana will affect access is not clear at this time. Aetna has posted its new prior authorization requirements for all hepatitis C drugs at http://tinyurl.com/aetnaHCV and does not appear to be restricting access based on severity of liver disease. How the preferred status of the Gilead drugs in Aetna’s plans will affect patient-provider choice if another regimen is clinically indicated is not defined in this document.
On January 12, 2015, the PBM Prime Therapeutics announced agreements with both Abbvie and Gilead in order to provide patients equal access to all state-of-the-art hepatitis C drugs. Prime Therapeutics indicated that the price negotiated for both drugs was low enough to warrant no preference in one drug over the other (the prices negotiated are confidential). At this time it is unclear how the agreements with Abbvie and Gilead will affect access for patients whose drug benefits are administered and fulfilled by Prime Therapeutics and how individual health insurers influence these benefits.
Prime Therapeutics serves primarily Blue Cross and Blue Shield plans around the country and it is up to the individual plans to determine prior authorization requirements. The Chief Clinical Officer for Prime Therapeutics, David Lassen, indicated on a January 16, 2015 call with Project Inform that he believes the timing of being a “fast follower” will benefit patients by encouraging the health plans that have restrictions based on severity of liver disease to loosen or eliminate these restrictions.
The reported details for all of these agreements are vague, as are the details of how PBMs work with various plans and who (the PBM or the insurer) makes the final decisions about patient access in each plan. With the exception of the agreement between Abbvie and Express Scripts, these deals do not claim to increase patient access to curative hepatitis C drugs. Many questions remain about how these agreements will affect patient access and patient-provider choice and what impact, if any, these agreements will have on existing prior authorization requirements.
As for public payers, the impact also remains to be seen. Medicaid managed care plans are typically serviced by PBMs. It is up to the Medicaid director in each state, however, to determine the coverage criteria for drugs or classes of drugs. Thus, even if one of the manufacturers strikes a deal with a PBM, the state serviced by the PBM may not follow the terms.
As Medicaid programs serve a large proportion of Americans living with hepatitis C, Project Inform continues to strenuously advocate for lower prices for public payers on the one hand, and less restrictive treatment criteria on the other. At the time of the writing of this article, the AIDS Crisis Taskforce announced successful price negotiations with Abbvie. Hopefully the lower price negotiated will encourage many states to pick up Viekira Pak for people with HIV who are coinfected with hepatitis C.
The expectation of hepatitis C drug price competition is increased patient access. Because of our fractured and largely for-profit drug delivery system, it is very difficult to assess whether any of these price negotiations will accomplish this. Ultimately, if access is not improved through these agreements then the manufacturers, the PBMs and the insurance companies win — making money on all sides — while patients living with hepatitis C lose, unable to access the drugs that can cure them of a chronic, infections disease.
Project Inform will continue to track developments as the manufacturers, PBMs, and insurers negotiate agreements, work to understand the details of these agreements, and advocate that patient access be a prime consideration in these negotiations and in the final decisions made by all insurers, including Medicaid programs, to allow appropriate access to life-saving hepatitis C treatment.