Industry Trends

Radar On Market Access: Prime PBM’s Studies Show Promise for Managing Opioids

November 20, 2018

Researchers from Prime Therapeutics LLC recently presented studies on two approaches to managing the use of opioid medications, AIS Health reported.

Researchers from Prime Therapeutics LLC recently presented studies on two approaches to managing the use of opioid medications, AIS Health reported.

In the first opioid study, Florida Blue, Prime and Walgreens piloted a program where pharmacists gave a one-page opioid safety guide to Florida Blue members whose claim histories showed high opioid and controlled substance use when they picked up opioid prescriptions from a Walgreens pharmacy. The guide explained safe use, safe storage, safe disposal and overdose prevention for opioids, and included information on naloxone, a treatment used to counter the effects of an opioid overdose.

The intervention group, of 753 Florida Blue commercially insured members with pharmacy benefits through Prime, was compared with a similar group who used a non-Walgreens pharmacy and did not get the safety guide. With the intervention, researchers found “a statistically significant four-fold increase in the likelihood of a member receiving naloxone the next time they picked up an opioid prescription.”

Prime says the collaboration between the plan, PBM and pharmacy shows it is possible to identify high-risk opioid utilizers and increase the dispensing of naloxone — in keeping with the FDA’s efforts to increase the antidote’s availability as a means to reduce opioid overdose deaths — through a targeted process.

“Prime is currently working with Walgreens to operationalize an expansion of this [safety guide] program,” says Patrick Gleason, Pharm.D., Prime’s senior director of health outcomes. “A broader rollout is expected in 2019.”

In the second study, Prime’s researchers set out to develop a high-dose opioid predictive modeling process for Medicare members to identify them early, before they become high-risk opioid users.

Prime says it determined that separate predictive models are needed for first-time opioid users vs. those already using the drugs, and this approach resulted in “highly accurate” predictive models scoring and ranking the Medicare members on their future likelihood of getting high-dose opioids.

“We will be incorporating opioid predictive modeling scoring and ranking into our Medicare clinical programs beginning in first quarter of 2019,” Gleason says.

Perspectives on MA Plans’ Use of Step Therapy in Part B

November 15, 2018

While many stakeholders have praised CMS’s move to allow Medicare Advantage (MA) plans to apply step therapy to drugs covered under Part B, others have cautioned that it could result in delays or restrictions in patients accessing much-needed medications, AIS Health reported.

While many stakeholders have praised CMS’s move to allow Medicare Advantage (MA) plans to apply step therapy to drugs covered under Part B, others have cautioned that it could result in delays or restrictions in patients accessing much-needed medications, AIS Health reported.

On Aug. 7, CMS issued new guidance allowing MA plans to use step therapy for Part B drugs as of Jan. 1, 2019. The letter also states that those MA plans that also offer prescription drug coverage may use step therapy to have a beneficiary use a drug under Part D before stepping to one under Part B.

Matt Eyles, president and CEO of America’s Health Insurance Plans, praised the administration’s move. He said, “patients and families deserve the prescription drugs they need at a price they can afford. The new CMS policy helps deliver on that promise while also helping to ensure patients continue to have access to safe, effective, and evidence-based care.”

Meanwhile, some groups expressed their concerns. In a letter to HHS Secretary Alex Azar, the American Medical Association said, “The AMA is concerned about the utilization management tools frequently used by PBMs and health plans to control costs, as they often have little clinical basis and can simply be a means of shifting costs in the system. For example, prior authorization and step therapy protocols can create significant barriers for patients by delaying the start or continuation of necessary medical treatment, which can negatively affect patient health outcomes.”

In an Aug. 8 research note, Leerink analysts noted that “pharmaceutical companies could be enticed to offer rebates back to payers and plans in order to gain preferred status at the front of a step-edit or risk losing volume as a second-line or later agent. In turn, these rebates will lower drug costs for Part B MA plans and patients, but also lower pharmaceutical revenues.”

Radar On Market Access: CVS, Cigna Preview What’s in Store After Their Deals Close

November 13, 2018

CVS Health Corp. — which is on the brink of closing its $69 billion purchase of Aetna Inc. — is offering up more details about the “revolutionary” new health care model it plans to create after the companies officially combine, AIS Health reported.

CVS Health Corp. — which is on the brink of closing its $69 billion purchase of Aetna Inc. — is offering up more details about the “revolutionary” new health care model it plans to create after the companies officially combine, AIS Health reported.

The Dept. of Justice approved the CVS-Aetna deal in mid-October, contingent upon Aetna selling its Medicare Part D Prescription Drug Plan (PDP) business to WellCare Health Plans, Inc. In addition, 23 out of the 28 states that must approve the transaction have now done so, and CVS is “well down the line” with the remaining five states, CEO Larry Merlo said on the company’s third-quarter earnings call. He said CVS now expects to close the deal before Thanksgiving.

Once the companies combine, CVS expects to glean “substantial” cost savings by better managing common chronic conditions, optimizing and extending primary care, and reducing avoidable hospitalizations, he said.

Merlo also noted that the effort to redesign the consumer experience will be an “increasingly important competitive differentiator” for CVS-Aetna.

“As a cornerstone of this work, we will have our first concept stores up and running early next year, and through these stores we will pilot the programs just mentioned and explore new services to better address the cost-quality-access challenges of consumers and identify the most effective and scalable solutions so they can be rolled out more broadly across our footprint,” he said.

Meanwhile, on the Cigna Corp.’s earnings call on Nov. 1, CEO David Cordani updated investors and analysts about the status of its pending purchase of Express Scripts Holding Co., which remains on track to close by the end of the year.

“Express has a very good track record of innovation…[and] we’ll be doing more of it together,” he said of the company’s plans post-close. He conceded that the marketplace “will always be in a wait-and-see mode,” but said Cigna’s customers are “positive” about the deal.

Radar On Market Access: New Opioid Law Has Implications for MA, Medicaid Plans

November 8, 2018

One year after the Trump administration declared the opioid crisis a public health emergency, the president signed The SUPPORT for Patients and Communities Act (H.R. 6), a bipartisan legislative package containing myriad provisions aimed at addressing the opioid epidemic. One of the main objectives of the law is to expand access to substance use disorder (SUD) treatment in Medicaid, AIS Health reported.

One year after the Trump administration declared the opioid crisis a public health emergency, the president signed The SUPPORT for Patients and Communities Act (H.R. 6), a bipartisan legislative package containing myriad provisions aimed at addressing the opioid epidemic. One of the main objectives of the law is to expand access to substance use disorder (SUD) treatment in Medicaid, AIS Health reported.

The new law contains certain flexibilities related to the IMD exclusion, which refers to a longstanding exception that prevented state Medicaid programs from using federal funds to cover care for patients in mental health and SUD residential treatment facilities with more than 16 beds. The primary change is that Section 5052 amends federal Medicaid law by giving state programs the option to cover care in certain IMDs, which may be otherwise not reimbursable for federal funds, for Medicaid beneficiaries aged 21 to 64 with an SUD for fiscal years 2019 to 2023. Through a state plan amendment, states may receive federal reimbursement for up to 30 total days of care in an IMD during a 12-month period for eligible individuals.

As a condition of receiving federal payments, states will be subject to a “maintenance of effort” provision that essentially says they have to maintain the same levels of funding for “what they’ve been doing in other areas of care, so having IMDs doesn’t mean you can cut back on some of the home and community-based services that were going on for opioid treatment,” remarks Stephanie Kennan at McGuireWoods Consulting. “It’ll be expensive for the states, but it’s important for the continuum of care. The trade-off is that you’ll have patients hopefully who are getting the kind of care they need faster and won’t need other things on the other end.”

As states add IMDs to their programs, plans will have to figure out who will be eligible and how to manage the care, “because not everyone is going to need inpatient treatment and it is only for 30 days,” adds Kennan. “And I think in general whether it’s Medicare or Medicaid, the plans are going to have to do some identifying and managing of patients, but in a little more detail than they had to do it before.”

Radar On Market Access: PhRMA, Feds Spar Over Where To Place Drug Pricing Details

November 6, 2018

The 15th of October turned into a day of dueling proposals on the best way for pharmaceutical manufacturers to provide consumers with more information on medication prices. America’s Health Insurance Plans (AHIP) tells AIS Health that it sees merit in the federal government’s approach, while the pharma industry’s plan falls short.

The 15th of October turned into a day of dueling proposals on the best way for pharmaceutical manufacturers to provide consumers with more information on medication prices. America’s Health Insurance Plans (AHIP) tells AIS Health that it sees merit in the federal government’s approach, while the pharma industry’s plan falls short.

It began with a pre-emptive strike in the morning when the Pharmaceutical Research and Manufacturers Association of America (PhRMA), stressing its commitment to price transparency, issued a press release.

The pharma lobbying group said all its member companies voluntarily agreed to take a new approach to direct-to-consumer television advertising that will “soon” direct patients on where to find “information about medicine costs, including the list price of the medicine, out-of-pocket costs or other context about the potential cost of the medicine and available financial assistance.”

Its only specific example of where such information might be placed was on a “company-developed website.”

On the afternoon of Oct. 15, CMS issued a proposed rule that would require prescription drug manufacturers to post the Wholesale Acquisition Cost for drugs covered in Medicare or Medicaid in direct-to-consumer television ads.

The HHS secretary would keep a public list of drugs advertised in violation of the rule, which would provide an exception to the posting requirement for drugs with list prices under $35 per month.

“We do see this as another positive move the administration is taking to bring drug prices down to earth,” AHIP spokesperson Kristine Grow said Oct. 22. “We don’t think PhRMA’s proposal goes far enough…and requiring consumers to go to a website is not in the best interests of transparency,” she adds.

“Our perspective is knowing the list price through an advertisement just helps patients have better conversations with their doctor — and we think pricing should be an important part of the conversation with that doctor,” Grow says.

Currently, direct-to-consumer ads by drugmakers are pushing such discussions outside of the doctor-patient relationship, Grow asserts.

Perspectives on CVS Bid to Lower Drug Launch Prices

November 1, 2018

In an effort to pressure drug manufacturers to temper their launch prices for new drugs, CVS Health Corp. is rolling out a program in which drugs that have a price exceeding a certain cost-effectiveness threshold will be excluded from coverage, AIS Health reported.

CVS will let clients refuse to cover drugs that have a price tag of more than $100,000 per quality-adjusted life year (QALY), provided they are not designated as “breakthrough”

In an effort to pressure drug manufacturers to temper their launch prices for new drugs, CVS Health Corp. is rolling out a program in which drugs that have a price exceeding a certain cost-effectiveness threshold will be excluded from coverage, AIS Health reported.

CVS will let clients refuse to cover drugs that have a price tag of more than $100,000 per quality-adjusted life year (QALY), provided they are not designated as “breakthrough” therapies by the FDA.

What’s unique about CVS’s move is where that cost-effectiveness threshold comes from: the QALY ratio is based on publicly available analyses from the Institute for Clinical and Economic Review (ICER), a nonprofit organization that conducts comparative-effectiveness research. Experts say it’s the first instance they’re aware of in which ICER is playing a formal role in a PBM or payer’s coverage decisions.

“In theory, I think it’s a great idea,” says Art Shinn, Pharm.D., president of Managed Pharmacy Consultants, LLC. “I think their quality of work is good,” he says of ICER. “From what I have seen of their studies, I think they’re nonpartial.”

However, in a letter sent Sept. 12 to CVS Health Corp. CEO Larry Merlo, nearly 100 patient groups urged him to reconsider the company’s new policy, saying that coverage decisions based on cost-effectiveness “ignore important differences among patients and instead rely on a single, one-size-fits-all assessment.” They also say that ICER’s cost-effectiveness analyses discriminate against the chronically ill, the elderly and people with disabilities by “using algorithms that calculate their lives as ‘worth less’ than people who are younger or non-disabled.”

CVS is not alone in taking steps to push back against high launch prices for prescription drugs. Express Scripts Holding Co., one of CVS Caremark’s chief rivals, “was actually the first to market last year with a more comprehensive and flexible program through our National Preferred Formulary called Exclude at Launch, which helps protect payers from high-priced drug launches,” a spokesperson wrote in an email to AIS Health.

Jayson Slotnik, a partner at Health Policy Strategies, LLC, says CVS’s move may be an attempt to compete with Express Scripts, as the two companies are “racing for market share” in order to demonstrate growth to investors.