Risk Of Developing Liver Cancer After HCV Treatment

Saturday, March 7, 2015

Experts Discuss: Cost-Based Treatment Decisions,Comparing Adverse Events of HCV Drugs And More...



Managed Care Minute: March 7, 2015
March 7, 2015

The American Journal of Managed Care’s convened a panel of experts to discuss the role of formulary management in the changing dynamics for hepatitis C.

The approval of Sovaldi (sofosbuvir) in December 2013 to treat hepatitis C revolutionized the treatment landscape for the condition. While cost debates followed—with widespread criticism of the 12-week $84,000 regimen of Sovaldi—Medicare and some private payers came up with a plan to ration treatment to the more advanced-stage patients. As Sovaldi sales reached $2.8 billion in the third quarter of 2014, Gilead announced the launch of Harvoni, a combination of sofosbuvir with ledipasvir, priced at $94,500 for 12 weeks. And then at year end in December, Abbvie announced the FDA approval of its regimen, Viekira Pak.

As formulary exclusivity deals have begun for these molecules, The American Journal of Managed Care convened an expert panel to discuss formulary decisions by pharmacy benefit managers and their influence on rational drug use.

The panel included Ed Cohen, PharmD, FAPhA, Senior Clinical Director, Walgreens; Matthew D. Harman, PharmD, MPH, Director, Clinical Pharmacy Strategies, Employers Health; Keith Hoffman, Phd, VP, Scientific Affairs, Adverse Events; and Steven Miller, MD, MBA, Senior Vice President and Chief Medical Officer at Express Scripts

Listen to the panel discussion here.
Segment 1: Formulary Exclusivity Deals
The panelists discuss the evidence that is weighed when determining whether or not to include a particular therapy on their regimens.

Segment 2: Rational Drug Use

While formularies should provide physicians the ability to treat any patient that walks into the office, there also need to be clinical exceptions that allow patients with mitigating circumstances to get any product clinically necessary.

Segment 3: Saving More Than $4 Billion in 2015

After Viekira Pak was approved, Express Scripts kicked off a spree of exclusivity deals with pharmacy benefit managers and health plans picking Harvoni or Viekira Pak. Steven Miller, MD, MBA, estimates this will save the US market $4 billion in 2015.

Segment 4: Making Cost-Based Treatment Decisions

Harvoni has shown results within the first 8 weeks of treatment, which would save costs, Matthew D. Harman, PharmD, MPH, does not think many patients or providers will be making cost-based hepatitis C treatment decisions.

Segment 5: Alleviating Adherence Concerns

The panelists discuss potential adherence issues considering Harvoni is a once daily pill while Viekira Pak is a 2-pill combination. Steven Miller, MD, MBA, explained that at 84 days, the treatment period is relatively short no matter what, which makes adherence less of an issue.

Segment 6: Setting the Bar for Hepatitis C Treatment Costs

Even with 2 drugs competing with one another and more coming soon, Ed Cohen, PharmD, FAPhA, does not believe additional competition in the marketplace will significantly drive down costs for a hepatitis C cure.

Segment 7: Comparing Known Adverse Events of HCV Drugs
A recent report from Adverse Events suggests that based on the pre-approval adverse events listed for Viekira Pak that Harvoni and Sovaldi may be safer, according to Keith Hoffman, Phd.

Segment 8: Putting Patient Safety and Outcomes First in HCV Decisions
Although the Adverse Events report found Viekira Pak may not be as safe as Sovaldi and Harvoni, Express Scripts complimented that information with its own real-world data from 85 million patients before choosing Viekira Pak.

The idea has been floated that the government should try buying the patent rights for Harvoni from Gilead Sciences in an attempt to improve access, but even if such a move was feasible, no one seems to think it’s a good idea.

Segment 10: Hepatitis C Costs in the Spotlight
In the last year the hepatitis C drug market has gained a lot of attention in the healthcare industry despite the fact that oncology as a specialty drug market has been very expensive for years now.

Segment 11: High Cost Trends Trickling Into Other Disease Areas
Although the marketplace has managed to come to a temporary solution for the high cost of hepatitis C drugs, Steven Miller, MD, MBA, expects to see more examples of similar high-cost drugs in other categories.

The situation with hepatitis C drug costs is setting an interesting precedent for the rest of healthcare and one that needs to be watched closely, according to Keith Hoffman, PhD.

Segment 13: Making HCV Care Sustainable for All Patients
Looking at the situation in hepatitis C and its potential impact on other conditions from a provider standpoint, Ed Cohen, PharmD, FAPhA, offers up many questions to which there may not be answers just yet.

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