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SB262: Asthma drug pricing transparency

...Democratic Sen. Yvanna Cancela...has introduced a bill that would apply the same standards toward drugs that treat asthma...SB262 largely copies provisions of Cancela’s 2017 legislation on diabetes drug transparency, which requires the drug manufacturer to submit information to the state related to the cost of the pricing of the drug, and explain to the state whether the drug has undergone a substantial price increase in the past two years...SB262

SB378: Drug pricing board

Proposed by Democratic Sen. Yvanna Cancela, this measure would establish a statewide Prescription Drug Affordability Board, charged with identifying certain prescription drugs with pricing that creates challenges for insurers and patients and that would recommend an upper price and payment limit on the drug...The bill lays out the structure, make-up and abilities of the board, funded by taxes on prescription drug manufacturers based on their market share and the required costs of the board. It also lays out a process for setting upper recommendations on prescription drug prices, including requiring the suggested limits become mandatory after 2024...SB378

AB303: Regulation of kratom products

Sponsored by Assembly Republican Leader Jim Wheeler, this bill would require the state pharmacy board to regulate and oversee the sale of kratom, a Southeast Asian tropical tree with leaves that contain psychotropic effects...The bill would also prohibit the sale of kratom products to children under the age of 18, or to sell any kratom products that have been altered to become “injurious” to a consumer. It sets a $1,000 fine and separate civil penalty up to $1,000 for violations...AB303

AB239: Opioid clarification bill

...this bill would make changes to the opioid prescribing law passed in the 2017 legislative session that prompted complaints by physicians in the interim. The legislation would, among other things:
- Codify certain definitions from pharmacy board regulations, including course of treatment and acute pain
- Allow providers to still prescribe a controlled substance after reviewing a patient utilization report if they determine the prescription is medically necessary
- Allow providers to prescribe a longer initial prescription for a controlled substance for the treatment of acute pain than normally allowed by law if medically necessary
- Remove a requirement that a provider make a good faith effort to attempt to review a patient’s medical records before issuing an initial prescription of a controlled substance for the treatment of pain unless the initial prescription is for more than 30 days or the medical records are relevant to the prescription
- Repeal requirements that providers consider certain factors — including whether there is reason to believe the patient is not using drugs as prescribed, the number of attempts by a patient to obtain an early refill of a prescription and the number of times a patient claims a prescription has been lost or stolen — before prescribing a controlled substance...AB239

- Improving regulatory procedures to encourage innovation

- Better integration into the international pharma market...READ MORE

Endo International Plc said...the U.S. health regulator has decided...not to include blood pressure treatment vasopressin in its list of drugs that can be used in compounding, in a boost to the drugmaker that makes the only FDA-approved version of the product...The company had sued the Food and Drug Administration in October 2017, alleging that the agency had improperly authorized the bulk compounding of hundreds of drugs, including “essentially a copy” of Endo’s Vasostrict...The agency’s decision renders the sale of compounded products containing vasopressin unlawful, unless manufactured using an FDA-approved product, Endo said...READ MORE

...the Department of Health and Human Services has put forward a series of initiatives aimed at lowering prescription drug prices, Medicare expenditures, and patient cost-sharing. The proposals run the gamut from increasing transparency of net pricing, to allowing the use of certain formulary management tools previously off limits to Medicare plans, to direct price controls...But, will they work? The federal government appears to think so. Several weeks ago, Secretary of HHS Alex Azar stated that "the models being announced create new incentives for plans, patients, and providers to choose drugs with lower list prices...[advancing] our priority of using HHS programs to build a value-driven healthcare system."...it's debatable whether HHS will achieve the twin objectives of lower drug spending and decreased patient cost-sharing as a consequence of implementing its series of initiatives. Some may not get implemented as planned, or not at all given the opposition they evoke. Others may result in tempering the growth in drug costs overall, but raising the amount patients must spend out-of-pocket, whether on premiums or patient cost-sharing...

Unlike several other markets, the U.S. consumer healthcare system generally does not allow for the “third leg” of health care: pharmacists prescribing prescription medicines...A U.K. pharmacy can be qualified as one of three general types in terms of the services it provides. The baseline or essential services... enhanced pharmacy services...The highest level...is called advanced...The more advanced level is the independent prescriber who is responsible for the assessment of patients with undiagnosed or diagnosed conditions, who makes decisions about the clinical management required, and who ultimately draws up a treatment plan...The United States is dipping its toe in the waters of pharmacy prescribing in such rural states as Idaho, and even California and Washington, but it is not a national structure. Filling gaps in care through pharmacist prescribing would strengthen community pharmacy’s value proposition within the healthcare system...READ MORE

The Nevada Dispensary Association is responding to a recent state audit that was critical of the seed-to-sale tracking system the marijuana industry uses, noting that auditors did not find cannabis was diverted to or from the black market and suggesting that confusion over new software led to reporting errors...State auditors found frequent discrepancies between the amount of sales that are logged into the seed-to-sale tracking software METRC, and those reported on state tax returns. The association, which represents numerous marijuana businesses, did not comment...but provided a statement to The Nevada Independent about the findings this week...The audit suggested that with data incongruencies between the tax returns and the software, the state could have been losing out on $500,000 in tax revenue in a six-month period...READ MORE

China has announced a plan to slash the Value Added Tax on 21 rare disease therapies and four active pharmaceutical ingredients, dropping it by 80% in a bid to stimulate the domestic rare disease therapy market and drop the prices of the therapies...China is currently suffering from a shortage of rare disease therapies; of the 44 globally available rare disease therapies, only 19 are currently marketed within China, and of these 19, all are priced out of reach for the average Chinese patient. And with an estimated population of nearly 20 million people suffering from a rare disease within China, this is a huge area of unmet need...

China will add fentanyl-related substances to a supplementary list of controlled narcotic drugs from May 1, the government said...The statement was jointly issued by the Ministry of Public Security, the National Health commission and National Medical Products Administration...U.S. Trade Representative Lighthizer said in March he would prefer to include China’s commitments to curb fentanyl in any trade agreement...READ MORE

Drug manufacturers earned an average of $1.58 in profit for every $1 they spent on the production and administration of diabetes drugs in 2017, according to a report released by the Nevada Department of Health and Human Services...But the diabetes drug report...found wide variations in the profitability of drugs used to treat diabetes based on data provided by manufacturers to the state. Although some drug companies reported losses, 69 percent reported of manufacturer reports indicated profits greater than the combined cost of production and administrative expenditures, including some with profits more than 20 times combined costs...The long-awaited report comes nearly two years after lawmakers passed a bill requiring manufacturers of diabetes drugs and PBMs to submit annual reports to the state detailing the costs associated with those drugs and explaining any price increases. The first report based on that information was initially slated to be released in September...READ MORE

NACDS and the National Community Pharmacists Association held a briefing this week for the Congressional Doctors Caucus...chaired by Rep. Phil Roe...comprised of 16 medical providers in Congress who use their medical expertise to develop patient-centered healthcare policy...NACDS and NCPA discussed the Centers for Medicare & Medicaid Services’ recently released proposed rule—Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses—and explained the serious repercussions of direct and indirect remuneration (DIR) fees and the impact they can have on patient access to care and on pharmacies, who are struggling to maintain their businesses amid the uncertainty caused by the retroactive fees. The groups noted that they have advocated strongly for DIR reform in the CMS proposal because it will benefit pharmacies and the patients they serve.