FDA approves UCB drug for Parkinson’s, restless legs syndrome
ATLANTA — The Food and Drug Administration has approved a patch for treating restless legs syndrome and Parkinson’s disease.
UCB announced the FDA approval of Neupro (rotigotine) transdermal system advanced-stage idiopathic Parkinson’s and moderate-to-severe restless legs syndrome.
"Neupro represents an innovation in the treatment of Parkinson’s disease and restless legs syndrome," UCB chief medical officer and EVP global projects and development Iris Loew-Friedrich said. "UCB is thrilled to make Neupro available to patients living with these serious diseases."
RxAlly hires John Miall
LEESBURG, Va. — A group that claims a membership of more than 20,000 pharmacies nationwide has appointed a new member to its leadership team.
RxAlly announced that it had hired John Miall as national practice leader for integrated care initiatives. Miall will work with payers, government agencies and others on commercial, self-funded, Medicaid and Medicare programs through medication therapy management and other pharmacist-based care models.
"I am eager to get started in supporting [RxAlly’s] mission of providing an unprecedented level of service to patients across the country that will ultimately improve health and lower costs for everyone," Miall said.
Miall previously worked for Miall Consulting, which provided counsel on prescription benefit programs to clients in the United States and Canada, previously working for the city government of Asheville, N.C.
NACDS submits comments to CMS regarding Medicaid pharmacy reimbursement provisions of healthcare-reform law
ALEXANDRIA, Va. — The National Association of Chain Drug Stores has submitted official comments to the Centers for Medicare and Medicaid Services regarding its proposed rule on Medicaid pharmacy reimbursement using the average manufacturer price model. The AMP model was reformed by the Patient Protection and Affordable Care Act.
In its comments, NACDS highlighted several areas of concern, including the definition of AMP, retail community pharmacy and wholesaler, when to calculate a federal upper limit, the amount of FULs and the importance of accurate Medicaid dispensing fees.
In its comments, NACDS expressed concern with AMP and its lack of correlation with pharmacy acquisition costs.
“It is important to note that AMP is not a price paid in the marketplace. In fact, analysis of the weighted AMPs published by CMS along with draft FUL lists, as well as government reports, indicate AMP is not a reliable benchmark for pharmacy reimbursement,” NACDS stated.
NACDS also urged CMS to “require states to re-evaluate dispensing fees to assure that they adequately cover costs and to include specific factors on assessing dispensing fees in this rulemaking.”
In addition, NACDS outlined the importance of ensuring that CMS wait until final rulemaking is completed before AMP-based FULs are used for pharmacy reimbursement. CMS has released seven draft FUL lists. According to NACDS, these draft FULs pose concerns for community pharmacy, as there is no regulatory process in place to ensure their accuracy since CMS withdrew the AMP rule in 2007.
“Due to the complexities outlined in our comments, we urge CMS to complete final rulemaking before implementing the pharmacy reimbursement provisions of the Affordable Care Act. We are committed to working with you to implement these provisions in a manner that complies with current law and maintains access to prescription drugs and pharmacy services for Medicaid beneficiaries,” NACDS stated.
The legislative language in the Patient Protection and Affordable Care Act that led to the development of a new proposed rule is a direct result of an important and successful multiyear effort to defend pharmacy patient care, NACDS noted.
NACDS and the National Community Pharmacists Association in November 2007 filed a lawsuit that challenged CMS’ prior implementation of the AMP model in the Deficit Reduction Act of 2005. In December 2007, a federal judge issued a preliminary injunction against that rule. NACDS and NCPA withdrew their lawsuit in December 2010 after CMS formally withdrew provisions of the AMP rule related to the definition of AMP, calculation of FUL and the definition of “multiple source drug.”
Also, NACDS submitted comments to the Office of Management and Budget regarding collection of National Average Drug Acquisition Cost data. In its comments, NACDS outlined several concerns, including the apparent lack of legal authority to collect NADAC, as well as conflicting information in the draft materials on confidentiality. NACDS comments also addressed the importance of comprehensive pharmacy reimbursement.