News from the Industry
Pharmacy DIR Proposal Supported by Nearly 3,500 Pharmacists, 150+ Pharmacy Stakeholder Organizations
January 29, 2019
by NCPA | Jan 29, 2019
ALEXANDRIA, Va. (Jan. 29, 2019) — A years-long effort led by the National Community Pharmacists Association to build support for a proposal to move pharmacy price concessions to point-of-sale reached a critical milestone on Jan. 25, 2019. Nearly 3,500 pharmacists and 170 patients formally voiced their support for parts of a proposed Centers for Medicare and Medicaid Services drug pricing rule that would eliminate the retroactive nature of pharmacy direct and indirect remuneration fees, or pharmacy DIR.
The proposed changes also received support from more than 150 pharmacy stakeholder organizations representing diverse interests, which unified their voices and submitted a joint letter of support to CMS. Additionally, more than two dozen patient advocacy organizations supported the proposed rule on the premise that, if finalized, the pharmacy DIR fixes will save the average patient nearly $200 per year or more in some cases on their out-of-pocket prescription drug costs.
NCPA submitted its own comments in response to the proposed rule, which is titled "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses." NCPA joined forces with the National Association of Chain Drugstores and the National Association of Specialty Pharmacy on a joint comment letter asking for a pharmacy DIR fee fix and standardized pharmacy metrics, and also also sent a joint comment letter with the American Society of Consultant Pharmacists and the Senior Care Pharmacy Coalition focusing on harm to seniors with proposed protected class changes, as well as on the need for a new definition of negotiated price and standardized pharmacy measures.
Several letters supporting the proposed DIR fixes are also being sent by members of Congress. Review letters of support for the pharmacy DIR provisions in the proposed drug pricing rule.
"NCPA had asked CMS to include all pharmacy price concessions at the point of sale – or, ideally, eliminate pharmacy DIR altogether – in response to the administration's request for information about its ‘Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs,'" said NCPA CEO B. Douglas Hoey, Pharmacist, MBA. "This proposed rule is evidence that we are being heard, and we applaud the administration for putting out this proposal to include pharmacy price concessions at the point of sale. Eliminating the retroactive application of these fees would provide much-needed predictability and stabilization to pharmacy operations, and would save Part D beneficiaries billions of dollars.
"Less uncertainty for pharmacies, lower costs for seniors – that's a no-brainer in our book. And as witnessed in comments to CMS, an overwhelming number agree.
"Now is the time to bring more transparency into our health care system and a reprieve to small business community pharmacies and seniors. We are grateful to the administration for recognizing this, and strongly encourage them to finalize this proposal. Community pharmacists are ready partners in this and other ongoing efforts to lower drugs costs and eliminate pharmacy DIR once and for all."
Founded in 1898, the National Community Pharmacists Association is the voice for the community pharmacist, representing 22,000 pharmacies that employ 250,000 individuals nationwide. Community pharmacies are rooted in the communities where they are located and are among America's most accessible health care providers. To learn more, visit www.ncpanet.org.
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FDA OKs Esketamine Nasal Spray for Treatment-Resistant Depression
March 5. 2019
Officials with the FDA have approved esketamine CIII nasal spray (Spravato, Janssen Pharmaceutical Companies of Johnson & Johnson) for use in conjunction with an oral antidepressant in adults with treatment-resistant depression (TRD). This is the first new mechanism of action in 3 decades to treat major depressive disorder (MDD).1,2
The approval follows a phase 3 clinical trial with more than 1700 adults with TRD. In a short-term study, those who took Spravato and an oral antidepressant experienced superior improvement in depression symptoms at 4 weeks, compared to those who received a placebo and an oral antidepressant. In a long-term study, patients in stable remission taking the medication who continued treatment with the medicine were 51% less likely to relapse versus those who maintained a regimen of a placebo and an oral antidepressant.
People who are currently struggling with MDD are considered to have TRD if they have not responded adequately to at least 2 different antidepressants of adequate dose and duration in the current depressive episode. It is estimated that approximately one-third of US adults with MDD have TRD.
Spravato carries a boxed warning regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behaviors in pediatric patients and young adults.
In the clinical trials, the most common side effects of Spravato when used along with an antidepressant taken by mouth included: dissociation, dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure, vomiting, and feeling drunk.
Once Spravato is determined as an appropriate treatment option, in accordance with the REMS, the patient will be treated at a certified treatment center that is trained to administer the medicine and address patient needs. The medication will not be dispensed directly to patients for home use. The health care provider will then observe the patient for treatment-emergent sedation, dissociation and blood pressure changes for at least 2 hours, until the patient is safe to leave. Patients should not drive or operate heavy machinery until the next day, following a restful sleep. All patients will be enrolled in the Spravato REMS registry to further characterize the risks of serious adverse outcomes from sedation, dissociation, abuse and misuse, and to support safe use of this medicine.
Spravato [Prescribing Information]. Titusville, N.J., Janssen Pharmaceuticals, Inc.
Johnson & Johnson Press Release. Janssen Announces U.S. FDA Approval of SPRAVATO™ (esketamine) CIII Nasal Spray for Adults with Treatment-Resistant Depression (TRD) Who Have Cycled Through Multiple Treatments Without Relief. https://www.janssen.com/janssen-announces-us-fda-approval-spravato-esketamine-ciii-nasal-spray-adults-treatment-resistant Accessed March 5, 2019.
Legislation re-introduced in Ohio to end PBM co-pay clawbacks & gag orders.
March 1, 2019
The fight to lower drug costs for Ohioans isn't over yet. In Ohio, State Representative Scott Lipps (R-Franklin)and Representative Thomas West (D-Canton) are again aiming to end a secretive practice that is causing patients to pay more than they should at the pharmacy counter. Specifically, they announced this week that they have introduced HB 63, legislation that would prohibit co-pay clawbacks and pharmacist "gag orders" that stand in the way of lower prices for patients at the pharmacy counter. Additionally, newly-elected Senator Tina Maharath (D-Columbus) companion legislation, SB 14, over in the Senate this week as well.
In the previous General Assembly, Reps. Lipps & West's HB 479, dubbed the "Prescription Drug Co-Pay Integrity Act," sought to prohibit the practice of pharmacy benefit managers (PBMs) requiring pharmacists to charge patients an amount greater than the pharmacy's cash price for a particular prescription drug. Second, the legislation would have prohibited "gag clauses" that some PBMs place in pharmacy contracts that penalize pharmacists for disclosing a complete picture of the financials of a patient's prescription drug transaction. Reps. Lipps & West have reintroduced the language in HB 63. Sen. Maharath's bill has been designated as SB 14.
This issue has received significant attention in the media in recent years, and it all started with a 2016 investigative report from a news station in New Orleans. Similar legislation has already been passed in more than a dozen states. The practice has resulted in more than 16 lawsuits across the country, as well as federal prohibitions on gag clauses signed into law by President Trump in October 2018.
As prescription drug prices continue to grow, 6 in 10 Americans say lowering the cost of prescription drugs should be a “top priority” for lawmakers. In Ohio, despite the failure of the unworkable "Drug Price Relief Act" (Issue 2), a message was sent that something must be done to get drug pricing under control. The Ohio Pharmacist Association (OPA) has worked extensively with lawmakers to address out-of-pocket expenses for patients and to shed light on a problem that OPA members have said must be stopped.
Last year, OPA stood alongside Reps. Lipps & West, and Holly Pendell, director of advocacy and activist engagement for the National Multiple Sclerosis (MS) Society, to announce the bill's introduction. To view that press conference in its entirety, see the Ohio Channel's video HERE. To view the discussion of the bill on the House floor, see the Ohio Channel's video HERE.
It's no secret that OPA has been very outspoken about the problems with prescription drug pricing (see here, here, here, and here). The Columbus Dispatch has spent a full year pulling back the drug pricing curtain in a special Side Effects investigative series that is exposing millions of dollars in drug pricing waste. We've spent a great deal of time working to reform a broken system that rewards big supply chain middlemen and results in higher drug costs for employers, taxpayers, and patients. The "Prescription Drug Co-Pay Integrity Act" is just one attempt at ensuring that patients aren't paying any more than they have to for their needed medications.
"We remain determined to expose and stop the malicious and greedy practices utilized by PBM’s to hurt our citizens and Ohio’s budget. We are excited to reintroduce House Bill 479, from the 132nd General Assembly, which eliminates gag rules and clawbacks. Governor DeWine and his administration are keenly aware of the millions of dollars PBMs have siphoned out of Ohio. It is time for all of us, including the Legislature, Managed Care Organizations (MCO’s) and Medicaid to work together and FIX this," said Rep. Lipps.
"Consumers shouldn’t be priced out of their health care, especially when cheaper options are available," said Senator Maharath.
"The clawback is just the one example of PBM tactics that deceive patients, inflate the cost of prescription drugs, and line the pockets of administrative middlemen," said OPA Executive Director Ernie Boyd. "Pharmacists should not be prohibited from empowering patients to save money, and PBMs should not profit off of the over-inflated co-pays that they set for patients at the pharmacy counter. It's wrong.".
Here's hoping that other states take note and follow suit!