Value and Access

LASER ANALYTICA’s diverse teams provide a full range of market access strategic services in a truly integrated model. In offering market access support, our specialists can deliver worldwide access to market services to our pharmaceutical and medical device customers.
Our services in this area include:

Services are either Discrete Services provided as standalone assignments or Integrated Consulting taking advantage of the knowledge and resources available in different specialized teams, assembled and put in perspective by top-level strategy consultants.

Market Access Strategies

We provide advanced market access consulting through:

  • Strategic consulting services on obtaining market access
  • Market access plans (global and local)
  • Reimbursement pathway analysis
  • Value messaging and evidence generation to fill gaps in product value

Typical market access engagements by LASER ANALYTICA may encompass the following:

  • In-depth investigation into the clinical and reimbursement landscape surrounding the given disease area
  • Critical review of health technology assessments in the disease area
  • Analysis of the value associated with the target product profile (TPP)
  • Key value attributes leading to best value proposition
    • Desired clinical and health economic evidence
    • Likely pricing and reimbursement potential
    • Data planning and requirements
    • Disadvantages, hurdles and barriers to market access
    • Global value dossiers and ancillary materials (objection handlers, mock negotiation, slide kits)
  • Directional guidance on how to successfully meet the future challenges driven by nuances in payer decision-making achieved through advisory boards and one-on-one interviews with payers
  • Quantitative analysis identifying the profit optimal price, willingness-to-pay, and value drivers for new agents

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Payer Research

A pioneer of payer research, LASER ANALYTICA helps its customers define their access strategy through:

  • Qualitative payer research (including interviews, ad boards and focus groups) to test product profiles, value messages, and market access strategies
  • Secondary research on P&R analogues to understand likely access, reimbursement and price decisions based on the product profile
  • Stakeholder engagement in key markets

Payer and HTA experience

LASER ANALYTICA consultants help clients assemble the most relevant case for a health product – globally and locally. Its teams demonstrate high proficiency in the modus operandi and criteria used by HTA agencies and payers such as:

  • US Payers, managed care, HMOs, Medicare, Medicaid;
  • European HTA: NICE, SPC, HAS, G-BA, AIFA, AOTM, several other CEE countries;
  • INESSS and other Canadian provinces; and
  • Global experience: e.g. China, South Korea, Australia, New Zealand.

Economic Modeling

LASER ANALYTICA’s consultants are expert in all aspects of pharmacoeconomics research and its applications. Hundreds of projects have been conducted or are ongoing in multiple therapeutic areas to produce:
  • Budget impact and cost consequence modeling
  • Cost effectiveness and microsimulation modeling
  • Market forecasting and revenue optimization
  • Quantitative pricing including discrete choice modeling and analog pricing
  • Cost calculators

Multiple perspectives are taken on these: US payers’ (different managed care organizations), EU payers’ (all countries, most regions within each), emerging market countries’ perspectives (BRIC, South Korea, other Latin America countries) Australia, New Zealand.

HTA Submissions

LASER ANALYTICA has prepared hundreds of local reimbursement submissions, including developing or adapting economic and budget impact models and communication with local health authorities. Each office has extensive local and regional expertise. In addition to internal expertise, we ensure research validity by targeting appropriate stakeholders across markets via a vetted panel of payers, former payers and payer influencers.

Our approach is in line with EUNetHTA Guidelines.

CORE HTA

The organization of health technology assessment and the setting in which HTA agencies operate vary considerably across and within countries. There is also a significant variability in the practical application of HTA-type approaches, and especially their linkage to the policy and reimbursement process. For this reason LASER ANALYTICA developed the CORE HTA methodology, bringing together the expertise of both the ‘Access’ and ‘Value’ specialists of the company.

The intention of CORE HTA document is to assemble within one single document the vast majority of the materials needed for developing local submissions, and as such, it includes a combination of formal descriptions of the various evidence, and strategic guidance as to how to use the evidence in submissions depending upon various local circumstances. The document is written in a modular fashion, so that it is possible to extract information with the level of detail appropriate for each individual user. The document consists of four major parts and includes:

  • overview of the challenges in the current landscape, burden of disease, available treatments and ultimately unmet needs,
  • detailed descriptions of interventions
  • overview of clinical effectiveness
  • overview of the available economic analyses

Our experience encompasses HTA dossiers & submissions across:

  • Europe: Germany (AMNOG); France (HAS); UK: NICE (England & Wales) & SMC (Scotland); Italy (AIFA, Lombardia, etc); Poland (AOTM), Spain; Belgium; The Netherlands; Finland; CEE  (Romania, Hungary, Bulgaria, Czech Republic, Slovakia, Croatia, Serbia, Slovenia, Estonia, Latvia, Lithuania), CIS
  • North America: Canada (CADTH; INESSS); (Quebec, Ontario, British Columbia, Alberta, Sasketchewan, Manitoba, New Brunswick, Nova Scotia, Labrador & Newfoundland, Public Health Authority, NIHB); US: AMCP
  • Rest of the World: Turkey, Russia, South Korea, China, Taiwan, Singapore, Hong Kong

Scientific Engagement

As clients move from insight into action, it is critical to engage patients, payers, regulators and clinical KOLs in the accumulation of data and analytics that will underpin the case for access and investment. The key objective is to leverage know-how and build alignment in a transparent and systematic way. The opportunities for multi-stakeholder engagement have proliferated rapidly in recent years, evidenced by the recent formalization of joint EMA-EUnetHTA advice. We have developed a range of high quality approaches to extract the maximum value out of all forms of scientific engagement throughout the development process, in a way that can be easily integrated within core operating models.

Regulatory engagement for real life success

Our Regulatory experience:

  • EMA, USFDA, MHRA, ANSM, AEMPS, AIFA, HPB, CEE countries

Joint HTA-Regulatory advice

Post-marketing commitments