Featured Case Study: Gene and Cell Therapies
A unique set of clients when it comes to reimbursement are the cell and gene therapy companies. We’ve worked closely with several and to say the work is “multi-variable” is an under-statement…. Connect 4 is built for these, since our core team has over 25 years of experience – each! And we bring a wealth of experience across reimbursement, clinical development, policy and advocacy. Not to mention, we were “at the front” protecting market access interests as previous wholesale changes were made to reimbursement structures, and apply that experience now.
We’re supporting companies through their reimbursement landscape/gap analysis only to find that a change in their clinical development approach or edits to their protocol at the FDA to be an important first step. Or that handling and storage adjustments are needed.
We participate in industry coalitions to ensure that efforts to change reimbursement structures through policy and lobbying are addressing niche needs identified in their market access analysis. We anticipate the potential for outcome-based contracting, we work closely with advocacy organizations on assessing patient journey data in extremely rare diseases, we anticipate ICER’s impact, and more. We’ve said it elsewhere here, but it couldn’t be more true for regenerative medicine – there are no cookie cutter solutions in this space.
It is a critical time of change for both commercial and government payers looking to address individual and collective circumstances of gene and cell therapies, and clients should not miss this opportunity to take a multi-faceted approach to their reimbursement analysis and actively take a role in changing its course. Companies large and small have been leveled to an even playing field with an equal voice with payers and policymakers interested in creative solutions that impact patients, providers…and investors.
SICKLE CELL DISEASE AND PRIORITY REVIEW VOUCHERS
Sickle cell disease is a rare and pediatric disease in dire need of new therapies. Patients living with sickle cell disease have few options and it is daunting to see how few therapies have been brought to market since President Nixon declared war on sickle cell disease at the same time as his more famous war on cancer. Any and all incentives to drive innovation should be heaped on this far too long ignored disease. Congress certainly saw it that way in 2012 when it passed the Creating Hope Act, creating the Rare Pediatric Priority Review Voucher Program. However, FDA interpreted the statute to exclude SCD.
Connect 4 spent significant time with patients and the community of parents, caregivers, physicians and others dedicated to seeing young people survive into adulthood. This community is inspiring and yet in need of a cohesive agenda and leadership. We worked with tireless advocates, who bravely took to the Hill, to FDA, and to the regulatory process. They far outnumbered any other interest filing comments with the agency on its Draft Guidance, which interpreted the statute to exclude SCD. All this advocacy was new for them. Yet, working together, we made a loud and sustained effort to have SCD recognized and included in the Rare Pediatric Priority Review Voucher. Along the way, we found other injustices in need of correction, and the community is inspired, and now more experienced, to take on another issue next in the fight for a level playing field for SCD! We have never been prouder of our work, and the relationships forged with patients, their physicians, and caregivers will remain.
Rare Diseases
Revenue Stream Analysis
Supporting Start-Up Innovation
Many of our valued clients are small start-up, early clinical stage companies whose CEOs are beating the bushes for investors. They need more than a “back of a paper napkin” estimate of revenue but less than a full blown plan of action to change the world. We have lots of experience in getting the details right without overwhelming the client, or overshadowing their immediate needs. Keeping it simple, for both the CEO and the investors they’re engaging, is a sure fire way to build a longer term partnership.
Our revenue estimates look at claims data when available, cross referenced to a setting-of-care mix and payer mix. We understand and work with the arcane reimbursement rules in each setting of care and across each payer every day, so we can keep costs down when serving CEOs’ initial investor presentation needs, and build on the analysis as warranted.
As products move from bench to market, we build out strategies to overcome any reimbursement challenges on an as-needed basis, understanding that the goal is sometimes sale of the asset or the company itself.
Addiction
MEDICATION ASSISTED TREATMENTS FOR PATIENTS FACING ADDICTION
Hired to work with Congress to update a statute made obsolete by the substance abuse epidemic facing our country, Connect 4 got to work dissecting what the Department of Health and Human Services could do unilaterally and where Congress needed to step in. We quickly began running parallel tracks, and saw opportunities for FDA, CMS, CDC, ONC and others to support SAMHSA’s efforts. Hampering access to medication assisted therapy and sustaining the stigma of treating addiction has no place during our current national crisis. We exposed competing financial interests fighting for their piece of the pie rather than securing sound public policy, and worked with our client to shape creative solutions that worked for patients. A multi-prong, multi-agency approach finally led to success. After years of failed attempts to change the statute, Connect 4 drove a regulatory and congressional strategy that increased access to evidence based treatments for the treatment of addiction.
Hire Connect 4 when you need a leader with years of experience assessing and driving success across a complex terrain of legislative and regulatory jurisdiction as well as provider and manufacturer interests. We are not a “siloed,” or “stay in your lane” firm that speaks only one language. We break down barriers, simplify goals and advocate for all stakeholders to move in one direction – to success!
Pain Management
ABUSE DETERRENT FORMULATION ADVOCACY
A company looking to distinguish itself in the Abuse Deterrent Formulation space before product launch recently hired Connect 4. We helped shape a Federal agenda, from Congressional activity to quality measures to patient and provider stakeholder engagement. Key Congressional introductions drove immediate results and put the Washington office on a trajectory for success. Not to mention a very successful, multi-faceted approach to the “open mic” part of their Advisory Committee meeting at FDA!
Hire Connect 4 when you want to understand and leverage key policy veins to your advantage.
Oncology
WHEN “J” CODES MATTER
Relaunching a drug has its own challenges. Connect 4 has recent experience in working on a relaunch, where the company discovered their new pricing strategy and accompanying contracting and marketing plans might be jeopardized by an old J code that was never retired by CMS. We identified the problem, educated the client on the countless implications for Medicare and commercial payers, and worked through the issue with the Regulatory, Commercial, and Market Access teams to ensure a positive change in time for launch.
Connect 4 is the partner of choice when the details matter and you're looking for more than pretty repackaged slides!
CUSTOMIZED SOLUTIONS FOR PERSONALIZED MEDICINE
In the accelerating world of personalized medicine, Connect 4 is an experienced partner in oncology. Connect 4 will think through any and all challenges or opportunities for reimbursement of any diagnostics you may be counting on being commercially viable by the time of your drug launch. Alerting a client to their Part B reimbursement concerns for the diagnostic when the client’s focus had been on their oral drug was key to planning ahead for payers’ medical benefit plans. Connect 4 works closely with the Washington office and the Market Access team to support a client’s Medicare work streams, ensuring up-to-date understanding of latest CMS policy changes at the national and MAC levels.
Connect 4 has a deep understanding of market access implications of commercial payer Prior Authorization policies, existing and competing non-FDA approved tests, and various government initiatives. Connect 4 was well aware of others companies' experience with "testing fatigue" and created new ways to improve testing for a client. We have strong experience in this area and can work with you to ensure a smooth and seamless launch strategy.
Oncology
Vaccines
ALIGNING PLAYERS TO ENSURE APPROVALS AND OPTIMAL REIMBURSEMENT
Vaccine reimbursement is an area fraught with exceptions to the rules of reimbursement. From CPT and CVX codes to statutory provisions to US Preventive Task Force Recommendations, don't just "wing it!" As you approach your FDA filing, think ahead to your strategies for CDC, ACIP, HHS, AMA and more. Connect 4 has deep experience in navigating a situation where FDA wanted to review an application faster because of a couple of high profile outbreaks on college campuses. However, faster review and approval wouldn't have guaranteed access without appropriate coding, and the coding schedule was on a slower timeline.
Creating a new standard, as well as the criteria by which that standard should be met, and ensuring this company's vaccine was the first one evaluated against the standard is the kind of creativity and timely execution you can expect from us. Coding was comfortably accomplished much sooner than the company had expected it, and upon FDA approval, claims were paid immediately. And while we were at it, we ensured appropriate code descriptors for the company's vaccine and competitors to come.
Vaccines
QUICK ACTION TO ENSURE SUCCESSFUL VACCINE STRATEGY IMPLEMENTATION
The rules around vaccines continue to confound even the government, as different agencies seek to better understand and carve out their roles in recommending, covering, coding, and paying for vaccines. A recent issue reminded us of this, as CDC/ACIP and CMS found themselves embroiled in a territorial issue over their individual roles in covering and paying for a vaccine. The manufacturer was quickly recognizing that their vaccine, and their patients, could be mired in a lengthy debate at their expense. Working quickly, we reached out to the relevant agencies, and solved the problem on time! And while we were at it, we identified key CMS documents that needed revisions to ensure there would be no confusion among providers. We also created a policy work stream to ensure appropriate agency collaboration, which the company's trade association then took on.
Call on Connect 4 Strategies, LLC for your vaccine strategies.