May 17, 2020

CVS launches new initiative to lower drug costs for consumers

pharmaceutical
pharmaceutical
Catherine Sturman
4 min
The US healthcare industry is undergoing a rapid transformation. Escalating healthcare costs, political uncertainty and technological innovation is lead...

The US healthcare industry is undergoing a rapid transformation. Escalating healthcare costs, political uncertainty and technological innovation is leading to a number of mergers and acquisitions, as well as new processes to deliver care that is patient centered and tailored to the customer journey.

The cost of prescriptions across the US is continuing to rise, leading many to not take essential medication. CVS Health has now launched a new initiative to tackle the rise of drug prices, maximise prescription benefits and deliver innovative tools which will give consumers greater control and access to choose cheaper medications and lower prescription costs.

The company’s new tool, Pharmacy Rx Savings Finder, will enable retail pharmacists to evaluate and seamlessly review a patient's prescription regimen, medication history and insurance plan information to provide individual prescription savings opportunities. It also enhances existing savings opportunities the company's pharmacy benefit manager (PBM), CVS Caremark, offers its clients, such as preventive drug lists that make medications for many common, chronic conditions available.

"Armed with the information available through our Rx Savings Finder, more than 30,000 CVS pharmacists can play an important role by helping patients save money on their medications, providing advice on how and when to take them, and ultimately helping them achieve better health outcomes," Kevin Hourican, Executive Vice President, Retail Pharmacy, CVS Pharmacy, explained.

In addition, CVS Caremark provides real-time, member-specific drug costs and lower-cost alternatives to prescribers through their electronic health record system and members through the portal and newly updated app. These programs are part of CVS Health's commitment to helping consumers find the lowest cost prescription drugs by offering more pricing transparency across the board.

At the point-of-prescribing, providers are able to see the member-specific cost for a selected drug, based on a member's coverage, along with up to five lowest-cost, clinically appropriate therapeutic alternatives based on the patient's formulary..

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"Consumers are faced with higher prescription drug prices than ever before and many of them are now paying for a larger share of costs out of their own pockets at the pharmacy counter due to growth in high deductible health plans," said Thomas Moriarty, Chief Policy and External Affairs Officer, CVS Health.

"Until now, patients haven't had the appropriate tools available to them to help them manage these costs. To address this, CVS Health is giving expanded tools to patients, prescribers and pharmacists so they can evaluate prescription drug coverage in real-time and identify lower-cost alternatives. We are committed to finding the right drug at the lowest possible cost for patients to ensure they are able to access and stay on the medications they need. That's our promise."

Through The Rx Savings Finder, pharmacy teams will be shown:

  1. If the prescribed medication is on the patient's formulary and is the lowest cost option available.
  2. If there are lower-cost options covered under the patient's pharmacy benefit such as a generic medication or therapeutic alternative with equivalent efficacy of treatment.
  3. If the patient may be able to save money by filling a 90-day prescription rather than a 30-day prescription.
  4. If neither a generic nor a lower-cost alternative is available, other potential savings options for eligible or uninsured patients where allowed by applicable laws and regulation

Early results show that prescribers accessing the real-time benefits information through their electronic health record switched their patient's drug from a non-covered drug to a drug on formulary 85% of the time. In addition, when the patient's drug is covered, prescribers using real-time benefits switch their patient to a lower-cost alternative 30% of the time. When the prescriber switched to a lower-cost drug, the difference was approximately $75 per prescription.

The technology will “eliminate the friction that causes workflow interruption and prescription abandonment,” noted Tom Skelton, CEO of Surescripts. “We are effectively taking the burden off the patient,” he says, “and arming providers with actionable patient intelligence, so they can have a conversation with their patient while they’re still in their office.”

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Jul 24, 2021

A guide to labelling compliance for medical devices

medicaldevices
Technology
healthcare
Compliance
Susan Gosnell
4 min
A guide to labelling compliance for medical devices
Susan Gosnell, Product Manager at Loftware, explains labelling compliance for small medical device manufacturers

Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.

Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.

But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it. 

On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.

Putting a plan in place

MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.

Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance.  They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.

When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.

Why labelling in the cloud offers a roadmap forward

Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.

The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.

When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.

A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.  

Future-proof technology

The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.

While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.

Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.

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