Radar on Market Access

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.

Radar On Market Access: FDA’s OK of Opioid Makes ‘Diversion of Even One Tablet’ Risky

November 15, 2018

When a highly potent new opioid formulation was approved by his agency on Nov. 2, FDA Commissioner Scott Gottlieb, M.D., downplayed safety concerns about AcelRx’s Dsuvia. He stressed the importance of the painkiller for military use and the “very tight restrictions being placed on the distribution and use of this product,” AIS Health reported.

When a highly potent new opioid formulation was approved by his agency on Nov. 2, FDA Commissioner Scott Gottlieb, M.D., downplayed safety concerns about AcelRx’s Dsuvia. He stressed the importance of the painkiller for military use and the “very tight restrictions being placed on the distribution and use of this product,” AIS Health reported.
In general, PBM and health plan experts say such restrictions likely will hold and keep the drug within its proper niche, and the regulatory green light for Dsuvia shouldn’t interfere with broad ongoing efforts to better manage opioid use in the U.S.
Dsuvia is a sublingual formulation of an established drug, sufentanil, that is delivered through a disposable, pre-filled, single-dose applicator. It’s seen as ideally suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible, including its potential use on the battlefield. Gottlieb notes that this opioid formulation, along with Dsuvia’s delivery device, was “a priority medical product” for the Pentagon because it fills a specific, though limited, unmet medical need.
“A single-dose applicator could potentially prevent abuse due to the complexity of removing it [i.e., the medication] from the applicator,” says Mesfin Tegenu, R.Ph., president of PerformRx, LLC. “However, because it is 10 times more potent than fentanyl and 1,000 times more potent than morphine, the diversion of even one tablet can be risky.”
Tegenu adds that restricting the sites where Dsuvia can be administered “is a good step in preventing misuse. However, there is no guarantee that such a diversion will not occur and contribute to the opioid crisis.”
Yet Sharon Jhawar, Pharm.D., chief pharmacy officer for SCAN Health Plan, doesn’t anticipate a significant problem with diversion of the strong medication.
“Our perspective on Dsuvia is it’s been approved only in specific health care settings by someone who is medically trained, and is really for severe, acute pain in which other opioids would not be enough,” she says. “And because of the requirement of the setting and who needs to give it, this isn’t a medication you’re going to see insurers have on their formulary.”

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: Sensor-Equipped Pills Draw Plans’ Interest

November 8, 2018

In a move that one expert says Medicaid plans will be watching closely, Magellan Health and the drug manufacturer Otsuka America Pharmaceutical, Inc. said Aug. 30 that they will work together to allow “select regional provider networks” contracted through Magellan to opt into a program involving the Abilify MyCite system, AIS Health reported.

In a move that one expert says Medicaid plans will be watching closely, Magellan Health and the drug manufacturer Otsuka America Pharmaceutical, Inc. said Aug. 30 that they will work together to allow “select regional provider networks” contracted through Magellan to opt into a program involving the Abilify MyCite system, AIS Health reported.
Abilify (aripiprazole) treats schizophrenia and other mental illnesses. The MyCite system comprises Abilify tablets embedded with sensors; patches that detect and record the date and time of the pill’s ingestion as well as physiological data like activity level; an app that lets patients review their data and enter additional information; and a web-based dashboard that lets providers and caregivers display and track a patient’s drug ingestion patterns over time.
A 30-day supply of all the components in Abilify MyCite costs $1,650, says John A. Bardi, vice president of public affairs and digital medicine business development for Otsuka.
One in five Medicaid enrollees has been diagnosed with a serious mental illness or other behavioral health issue, and there’s likely another one in five who are undiagnosed, says Jeff Myers, president and CEO of Medicaid Health Plans of America. “So anything the plans can get [in their] tool belt to ensure adherence to their drug regimen, to do what we can to keep them well, is something the plans are going to look at very carefully.”
Down the road, if states consider adding Abilify MyCite to their carved-out formularies, or if managed care plans begin to roll it into their formularies, “the states are going to have some questions about how are you going to manage the benefit, and are we going to get the value out of spending this extra money,” Myers says.
To that end, insurers are particularly interested in learning whether the Abilify MyCite system can reduce hospital stays among the population that Magellan and Otsuka study, he adds.

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.