From the desk of Mitchell Stein
Good morning. I talk about randomized controlled trials a lot. Given the subject of this newsletter, that makes sense. This week, two items give us the opportunity for a great primer on the topic – see the first entry in Industry News below for more. Of course, we’ll spend some time on the proposed change in Medicare Part D plans (using step-therapy) along with the rest of the week’s news. This week’s full line-up is:
ICER in the news – Final endometriosis report and final condition update on plaque psoriasis
Inside the Beltway – Medicare Advantage plans get step-therapy, President’s latest vow to lower drug prices, Congress pushes back on rebate changes, overview of Administration’s plan, interview with CDER Director Woodcock, a subscription model for Hep C and the possible future of MD drug law
Industry Trends – RCTs, Express Scripts new formulary exclusions, Humana suit, CVS rebate numbers, CVS-Aetna deal, Express Scripts-Cigna deal, Rite Aid-Albertsons (non)deal, Alzheimer’s bad news consensus
Now, on to the news.
ICER In The News
ICER released a Final Evidence Report and Report-at-a-Glance on elagolix (Orilissa, AbbVie), for the management of moderate to severe pain associated with endometriosis. Because elagolix’s price aligns with clinical benefit only when compared to no other treatment, insurers may first encourage patients to try oral contraceptives and leuprorelin acetate before progressing to a new treatment that has an unknown long-term safety profile.
Institute for Clinical and Economic Review Final Report Highlights Limitations in Evidence on Long-term Safety and Effectiveness of Elagolix for Endometriosis, Discusses Options for Insurance Coverage Criteria
ICER released a Final Condition Update report and Report-at-a-Glance on targeted immunomodulators for the treatment of moderate-to-severe plaque psoriasis. ICER first reviewed treatments for plaque psoriasis in 2016. This update incorporates new clinical data and cost information for previously reviewed therapies, and includes analyses of more recently approved medications guselkumab (Tremfya, Johnson & Johnson), tildrakizumab (Ilumya, Sun Pharma/Merck), and certolizumab pegol (Cimzia, UCB), as well as risankizumab (AbbVie), which is currently being reviewed by the FDA. Policy recommendations repeat calls for insurers to minimize step therapy requirements on these treatments that are priced in alignment with clinical benefits, but cautions manufacturers against the ongoing price increases that are beginning to threaten the cost-effectiveness of entire therapy class.
Institute for Clinical and Economic Review Updated Report on Targeted Treatments for Plaque Psoriasis Finds Guselkumab and Risankizumab Offer Superior Health Benefit Compared with TNFα Inhibitors
ICER is growing! Interested in joining the ICER team? Check out our open positions in research, health economics, program management, and more on ICER’s Careers Page. This week’s job spotlight: The role of the CSO includes oversight of a skilled research team at ICER and the overall production of ICER reports, management of ICER’s engagement with outside academic researchers, and leadership in the evolution of ICER’s methods of value assessment and report development. The CSO will be a key member of ICER’s Senior Management Team and a central figure in ICER’s strategic planning and all other high-level activities.
ICER is growing! Interested in joining the ICER team? Check out our open positions in research, health economics, program management, and more on ICER’s Careers Page.
This week’s job spotlight:
The role of the CSO includes oversight of a skilled research team at ICER and the overall production of ICER reports, management of ICER’s engagement with outside academic researchers, and leadership in the evolution of ICER’s methods of value assessment and report development. The CSO will be a key member of ICER’s Senior Management Team and a central figure in ICER’s strategic planning and all other high-level activities.
Inside the Beltway/State Regulatory Developments
CMS announced this week that Medicare Advantage plans would be able to use step-therapy. The announcement is another piece of the Administration’s efforts to lower drug prices. Unlike other pieces of the plan, manufacturers were not pleased with this step, while insurers and PBMs thought it was a positive step. Some patient groups were opposed, but some, like David Mitchell, president of Patients for Affordable Drugs, saw the move in a more positive light: “I understand because I have a disease that will kill me if not treated correctly,” Mitchell said. “But if science says drugs are equally effective, I’m OK starting with the cheaper one.” Two articles below, from BioPharmaDive reviewing the changes and the second from The Hill reviewing stakeholder reactions.
First Published on The Centers for Medicare and Medicaid Services on Tuesday said it will allow Medicare Advantage plans to use step therapy for certain physician-administered drugs in Medicare Part B next year, aiming to curb drug costs. Step therapy allows plans to steer patients to the most preferred therapy, moving them to other therapies only if necessary.
A new federal policy intended to drive down drug prices could have a negative effect on patients, particularly those with chronic conditions, according to health advocates. The policy announced Tuesday by the Department of Health and Human Services will give some private insurers the option to require patients try cheaper drugs before turning to more expensive ones, regardless of what their doctor prescribes.
The President once again says drug prices will drop “substantially.” Donna Young of S&P Global reports including a review of his previous statements.
One of the components of the administration’s plan we know is coming is revisions to rules regarding drug rebates. The Hill reports on lawmakers pushing back on the impending rule change.
Two top Republicans are urging the White House to complete a thorough economic analysis before releasing a new policy that could completely upend the way prescription drugs are purchased.
Helpful overview of the Administration’s drug price plan from Sarah Jane Tribble of Kaiser Health News.
Three months after President Donald Trump announced his blueprint to bring down drug prices, administration officials have begun putting some teeth behind the rhetoric. Many details have yet to be announced.
RAPS Zachary Brennan interviewed Director Woodcock on the CDER reorg and other topics.
Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), answered a few questions by telephone from Focus on Friday afternoon. Below is a lightly edited transcript of the questions and answers.
Can a subscription model work for Hep C drugs? Louisiana wants to give it a try. (Note this is a STAT Plus article, behind a paywall.)
I n a bid to lower its costs for hepatitis C medicines, Louisiana officials are exploring a novel approach in which the state would make subscription-based payments to drug makers. Essentially, the state would agree to pay a fixed amount of money over several years for unlimited access to medication for anyone who is enrolled in the state Medicaid program or incarcerated in a state prison.
A discussion in the NEJM by Christopher Robertson, J.D., Ph.D. on the possible future for the Maryland drug price law that was overturned.
RCTs are fundamental to science. However, with the passage of the Cures Act and all the talk of “big data,” some seem to think their peak usefulness is behind us. I would argue that’s not the case – In this Medscape piece, Dr. Prassad discusses when they are appropriate and when they are not. (tl:dr – No, you don’t need an RCT for parachutes, but there are very few interventions that are analogous to parachutes.) A second piece is a bit outside our usual scope but drives home the point of the continued need for RCTs. Dr. Aaron Carroll (Midwest CEPAC member) writing in the NY Times (Workplace Wellness Programs Don’t Work Well. Why Some Studies Show Otherwise) discusses a unique study. More relevant than the topic itself was the study design and analysis. It showed not only the results of the RCT but what results would have looked like if an observational study had been done. Showing how the random trial differs from potential observational trial results is a thing of beauty (the results of the RCT were the opposite of the observational study results).
Recently I watched a debate unfold on Twitter over whether we should run a randomized controlled trial (RCT) of the inferior vena cava (IVC) filter for patients with a venous thromboembolism (VTE) and a contraindication to anticoagulation. Like witnessing a car accident, I was horrified but could not turn away.
Express Scripts released its list of formulary exclusions. According to the FiercePharma report: “Express Scripts barred 48 drugs from its national preferred formulary—22 of which compete against generics, 12 whose rivals use the same active ingredient at a lower net cost, and 11 that bear cheaper brand or biosimilar alternatives.”
It’s that time of year again-the time when lead PBM Express Scripts ignites pharma’s ire with a brand-new list (PDF) of formulary exclusions. This time, Express Scripts barred 48 drugs from its national preferred formulary-22 of which compete against generics, 12 whose rivals use the same active ingredient at a lower net cost, and 11 that bear cheaper brand or biosimilar alternatives.
Humana added its voice to the chorus alleging a conspiracy of generic drug manufacturers to set prices. They filed their own suit against them in the wake of both federal and state investigations.
Humana has filed a lawsuit against more than two dozen pharmaceutical companies for conspiring to fix the prices of widely used generic drugs, a scheme that forced the insurer to pay for drugs at artificially inflated prices. The complaint, filed in the U.S.
With PBM rebates continuing to make the news, CVS stated on their earnings call that they only retained 2% of the rebates they negotiated which represented 3% of their earnings per share. However, questions remain as to what CVS includes in their number; are there other payments from manufacturers they are not counting as rebates?
In a move to increase drug price transparency, CVS Health said its retained share of rebates negotiated with drug makers comes to 2%, which will translate this year to 3% of the company’s annual earnings per share or about $300 million.
Speaking of CVS, their deal with Aetna was also in the news this week with the AMA coming out against the merger and leaks that the Justice Department doesn’t see antitrust problems with the deal (two stories, the first from US News, the second from Bloomberg).
And speaking of deals, the Express Scripts – Cigna deal has both detractors (Icahn) and supporters (Robbins). Here is a HealthCareDive piece on Cigna’s response (Cigna claps back at Icahn in defense of Express Scripts acquisition). Below is this morning’s (8/10) update from Axios.
We’ve got yesterday’s drama recapped
Continuing the stream of deal news, Rite Aid announced they were calling off their merger with Albertsons (NY Times).
The Rite Aid pharmacy chain announced on Wednesday it had called off its proposed merger with Albertsons, the grocery retailer, after the deal appeared to lose the support of its shareholders. The announcement came on the eve of a special meeting of Rite Aid shareholders to consider the merger.
When the Biogen Alzheimer’s results came out a few weeks ago, we talked about how the narrative regarding the results had not yet jelled. Well now it has – as review continued of the “positive” results, the skepticism only grew. Now, sadly, few think there is any “there” there.
Biogen’s high-stakes Alzheimer’s gamble is being roasted by the experts. Is the amyloid beta theory dead?
Biogen $BIIB and its partners at Eisai had hoped to breathe some new life into the increasingly wobbly amyloid beta theory for Alzheimer’s when they sounded an upbeat note about their latest data cut on BAN2401. Instead, the controversy over the trial design in the face of growing doubts about