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Are you ready for the mandatory transition to eCTD for prescription medicines?

Mandatory Transition to eCTD

In October 2018 the TGA announced the long-awaited timelines for transition to eCTD. A staged implementation has been proposed for prescription medicines to reflect the current industry uptake of the eCTD format. The transition begins with new chemical entity, new biological entity, biosimilar and new combination medicine applications; with a proposed implementation by first quarter 2019. The timelines for Stage 2 (other Category 1 applications) and Stage 3 (variations and other types of applications) are 1 October 2019 and 1 July 2020, respectively.

The TGA consultation on the Transition to eCTD only for prescription medicines closes on 4 December 2018 and it is an opportunity to provide feedback on how the staged transition to eCTD will impact your organisation.

The transition to eCTD may seem daunting for companies who have not “taken the plunge”, and with valid reason, as it is not a simple project. Acquiring eCTD software will require considerable planning and resource before you are up and running. Some of the key steps to consider in planning your transition include defining your publishing requirements, investigating software solutions, selecting a vendor, procuring software, preparing IT systems, installing software and training.

Full or partial outsourcing of eCTD publishing is an alternative option which can support your transition to eCTD. Outsourcing can provide a cost and time effective solution for accessing eCTD software and publishing expertise. Partial outsourcing is also an option for increasing publishing capacity and access to local publishing resources in the same time zone can assist with meeting short deadlines.

 

To discuss how Commercial Eyes can assist you with all your eCTD outsourcing needs, contact our Regulatory Services team at [email protected]

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November 2018 PBAC Meeting Agenda

The November 2018 PBAC Meeting is scheduled to conclude today. Here, the Commercial Eyes Market Access team provides an analysis of the meeting agenda, including Sponsors with multiple submissions and the nature of requested listings by type.

 

 

The Commercial Eyes Market Access can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment. Contact us on (03) 9251 0777 to learn more about our PBAC Outcomes Database and let us help you envisage, achieve and defend the optimum market access outcomes for your business.

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Patient programs for improved patient outcomes

In the digital age of present, patients have never been better equipped with the devices and technologies to take control of their own healthcare needs and outcomes. With the ease of online access to tools such as patient forums, advocacy groups and self-assessment sites to name a few, patients are well informed and able to play a strong role in the dialogue of their own health care matters. This has ultimately led to a feeling of empowerment among the patient community, as well as an expectation to be heard.1

This shift in perspective is leading pharmaceutical companies to focus on patient centric services and technology-based solutions. In a survey of over 200 patient services executives from the US and European industries (Accenture 2016), 85% of companies said they would be raising their investment towards a patient-centric approach over the next 18 months (Figure 1).2

Figure 1

Accenture. The patient is in pharma’s growing opportunity in patient services. 2016

Accenture. The patient is in pharma’s growing opportunity in patient services. 2016

 

In the same survey, 95% of respondents said they would be planning to invest in patient engagement technologies during the next 18 months (Figure 2), showing the industry trend towards alignment with the ever more technology-focused patient.

Figure 2

Accenture. The patient is in pharma’s growing opportunity in patient services. 2016

Accenture. The patient is in pharma’s growing opportunity in patient services. 2016

Of the top ten patient services cited by surveyed patients as ‘extremely valuable’ (Accenture 2016), those which received the highest patient value included:

  • Medication delivery/support (85%)
  • Benefit coverage and access support (79%)
  • Remote monitoring (79%)
  • Patient outreach, reminders, scheduling (79%)
  • Adherence program management (77%)

 

Based on these figures it is not surprising that Pharmaceutical companies are focusing more and more closely on patient programs as initiatives to improve access to, usage of and adherence to medicines. Spending on these solutions has increased by nearly threefold in recent years as companies strive to deliver improved patient outcomes.3

In response to the top two patient rated services above – medication and access support – pharmaceuticals companies are looking towards medicines access programs (MAPs) to allow for a deferred cost of, or cost-free or subsidised access to medicines which do not have the relevant funding in place. For example, free access to medicines for indications which are not included within a funded scheme, e.g. clinical trial, and usually involving life-threatening conditions (compassionate access programs) or free access to medicines which are TGA-approved, however have not yet reached government reimbursement via the Pharmaceutical Benefits Scheme (PBS) (patient access programs).4 These are examples of the types of patient programs we can expect to see continued industry growth and investment in.

How can we help?

At Commercial Eyes, we have expertise in the development of online and paper-based patient programs, including compassionate access programs, patient access programs, product familiarisation programs (PFPs), patient support programs (PSPs) which can also involve the use of nurse support. We have collaborated with centralised pharmacies to allow for supply management direct to patient and have worked on nominated pharmacy models alike. We are passionate and excited about the upward trend towards patient services and can provide advice, support, assistance and expert project management for programs tailored to our clients’ needs.

For more information on how we may be able to help you develop a successful compliant Patient Program please contact me[email protected]

 

  1. Therapeutic Innovation & Regulatory Science 2017, Vol. 51(4) 460-467
  2. The patient is in pharma’s growing opportunity in patient services. 2016. Online access July 2018
  3. Patient Support Programs That Deliver Results. 2015. Online access July 2018
  4. Managing Medicines Access Programs. 2015. Online access July 2018

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PBAC Meeting Outcomes – July 2018

The July 2018 PBAC Meeting Outcomes were published on 17th August 2018. With 64 outcomes in total, the Commercial Eyes Market Access team provides an overview of PBAC decision making, including additional analysis conducted on biosimilar and oncology submissions.

 

PBAC Meeting Outcomes

 

The Commercial Eyes Market Access can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment. Contact us on (03) 9251 0777 to learn more about our PBAC Outcomes Database and let us help you envisage, achieve and defend the optimum market access outcomes for your business.

 

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Public Submissions to the August 2018 PBAC Special Meeting – Part 2

In the second part of this two-part series (Read Part 1 about here) we bring you further insight into opinions from the public submissions to the August 2018 PBAC Special Meeting.

Opinions from the Public Submissions


28 public submissions were received regarding the PBAC considerations for PD-1 and PD-L1 checkpoint inhibitors for multiple cancer types.

 

Do you think that different evidentiary requirements are appropriate for rare cancers?

 

YES – 64%   NO – 4%

No answer provided – 14%
Not published – 14%
Other* – 4%

 

* ”There are no set evidentiary requirements for applications seeking PBS listing of a drug, other than that the available data be presented systematically, in an unbiased manner and present evidence of comparative efficacy, safety and cost-effectiveness…”

 

How do you think cost-effectiveness should be established in this case?

A number of submissions commented on managed entry agreements and evidence development. A shared funded access mechanism could be applied where, after commencement, fit-for-purpose data could be collected prospectively to confirm the biological rationale and effectiveness of the product.

Multiple submissions stressed the generation of real-world outcome data for populations with rare and less common cancers as critical.

Do you think it is possible for the PBAC to satisfy itself that treatment with a PD-1 or PD-L1 checkpoint inhibitor is cost-effective without an economic model that is specific to that kind of cancer? How?

A number of submissions commented on the difficulties and challenges of determining cost-effectiveness without an economic model, or assessment of multiple indications within a single economic funding model. In the absence of multi-tumour data, there is significant uncertainty, and a greater tolerance of uncertainty may be justified in situations of high unmet need.

Some submissions provided possible approaches to establishing cost-effectiveness across cancer types:

  • Develop a separate model for each cancer type included in the multi-tumour list and perform separate cost-effectiveness analyses to identify the tumour type(s) where the drug is cost-effective
  • Develop a single, comprehensive model to simultaneously inform cost-effectiveness in multiple cancer types with the possibility of clustering different but related tumours types (e.g. similar natural progression, treatment approach). This model could allow estimation of incremental cost-effectiveness ratios (ICERs) of individual tumour types based on the relative prevalence and utilisation of the proposed drug in each tumour type
  • In the absence of an economic model, establish scores of clinical value (e.g. ESMO Magnitude of Clinical Benefit Scale (MCBS), ASCO value framework) and link price to scoring systems
  • Follow-on indication pathway: resources are devoted at the start of the agreement to define the populations and clarify expectations of the evidence and cost-effectiveness. For follow-on indications in the 3-year risk-sharing deeds, cost-effectiveness is verified at the end of the agreement period and this could be accomplished using a multi-indication model using pre-agreed principles
  • Rare cancer pathway: a pay-for performance type approach to medicines access should ideally not require the construction of, or evaluation of, a traditional PBAC-level economic model. This approach, in this population, controls expenditure and maximises value for public money by ensuring funds are spent when response (as a measure of effectiveness) is confirmed


FDA – 3 submissions referenced the FDA’s decision to consider pan-tumour indications and the approval of Keytruda® (pembrolizumab).

MA OIT – 4 submissions referred to the Medicines Australia’s (MA) Oncology Industry Taskforce’s (OIT) preliminary research into innovative international models for subsidy consideration across multiple indications. This found that there are various initiatives underway in overseas health systems (Belgium, Denmark, Netherlands, Germany and Italy). As per Medicines Australia: “While many of these agreements would not fit within the Australian legislative requirements, there are elements (e.g. initial horizon scanning of upcoming indications) that could be quite useful locally.” For further information, please refer to the submission by Medicines Australia: http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/agenda/pdf/august-2018-special-meeting/submission-27-medicines-australia.pdf

Outcomes of the PBAC’s considerations will be published through the PBS website scheduled for 28 September 2018.

Abbreviations: PBAC = Pharmaceutical Benefits Advisory Committee; PD-1 = programmed cell death-1; PD-L1 = ligand of PD-1 receptor; ICER = Incremental Cost-Effectiveness Ratio; ESMO = European Society for Medical Oncology; MCBS = Magnitude of Clinical Benefit Scale; ASCO = American Society of Clinical Oncology; FDA = Food and Drug Administration; MA = Medicines Australia; OIT = Oncology Industry Taskforce

Source: Pharmaceutical Benefits Scheme

 

The Commercial Eyes Market Access team has extensive experience in pricing and reimbursement and can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment. Contact us on (03) 9251 0777 to learn more and let us help you envisage, achieve and defend the optimum market access outcomes for your business.

This article was written by Michelle Yassa, Market Access Consultant.

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Public Submissions to the August 2018 PBAC Special Meeting – Part 1

In the first of a two-part series, we provide insights into opinions from 28 public submissions to the August 2018 PBAC Special Meeting held on 17 August 2018 regarding considerations for PD-1 and PD-L1 checkpoint inhibitors for multiple cancer types

 

28 public submissions were received regarding the PBAC considerations for PD-1 and PD-L1 checkpoint inhibitors for multiple cancer types.

 

  • Consumer organisation/research
  • Government HTA agency
  • Patients/individuals
  • Pharmaceutical industry
  • Professional organisation
  • Research and other – PBAC evaluation group



Opinions from the Public Submissions


Should the PBAC set aside one of its meetings each year to consider only PD-1 or PD-L1 inhibitors for cancer

Potential advantages of the PBAC’s consideration:

  • Timely & equitable access
  • Provides clinicians with flexible treatment options
  • Efficiency gains in the assessment & evaluation of data
  • Reduces PBAC workload
  • Budget certainty for government & sponsors
  • Opportunities for innovative pricing arrangements
  • Maintain reputation as a world leader in HTA & delivery of innovative medicines to Australians
  • Social justice

 

Potential disadvantages of the PBAC’s consideration:

  • Uncertainty with efficacy & safety data, cost-effectiveness & budget impact
  • Facilitating access to treatments that may be ineffective and/or harmful – opportunity cost
  • Accessibility to biomarker testing
  • Indication leakage
  • Timing may be premature given the number of ongoing trials, putting further PBAC applications at risk of heavy scrutiny
  • Equity across therapeutic areas
  • Increasing financial burden & burden on evaluation of cost-effectiveness
  • Limitations of current regulatory framework

What is the minimum level of evidence of effectiveness you think should be required before PD-1 and PD-L1 checkpoint inhibitors are considered for subsidy for a particular kind of cancer?

Aside from commenting on flexibility or responses not published/provided, five public submissions all stated that earlier phase, single-arm evidence should be made acceptable. Four submissions stressed the importance of subgroup analyses according to diagnostic assays such as biomarker expression.

The three government HTA agencies who provided public submissions had differing views: no minimum level of evidence should be required, single-arm evidence should be acceptable, or there should not be any difference in the level of effectiveness required for treatment subsidy in any therapeutic area.

Other views included evidence development and managed entry agreements rather than extrapolating evidence across tumours, with real-world data collected prospectively to confirm the biological rationale and effectiveness. A few submissions commented on a pay for performance model in the case of rare cancers, where effectiveness would be determined at the level of the individual.

Tune in next week for Part 2 of this series.




Abbreviations: PBAC = Pharmaceutical Benefits Advisory Committee; PD-1 = programmed cell death-1; PD-L1 = ligand of PD-1 receptor; HTA = Health Technology Assessment; MSAC = Medical Services Advisory Committee; IFNγ = Interferon gamma; TMB = Tumour Mutational Burden; dMMR = deficient mismatch repair; MSI-H = High Microsatellite Instability

Source: Pharmaceutical Benefits Scheme

 

The Commercial Eyes Market Access team has extensive experience in pricing and reimbursement and can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment. Contact us on (03) 9251 0777 to learn more and let us help you envisage, achieve and defend the optimum market access outcomes for your business.

This article was written by Michelle Yassa, Market Access Consultant.

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PBAC Special Meeting – August 2018

The August 2018 PBAC special meeting is scheduled for 17 August 2018 to consider options for listing PD-1 and PD-L1 checkpoint inhibitors for the treatment of multiple tumours (pan-tumour indications) on the PBS. Here, the Commercial Eyes Market Access team provides an overview of previous PD-1 and PD-L1 inhibitors submissions, including an additional analysis conducted on post listing utilisation.

 

The Commercial Eyes Market Access can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment. Contact us on (03) 9251 0777 to learn more about our PBAC Outcomes Database and let us help you envisage, achieve and defend the optimum market access outcomes for your business.

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Making the most of complementary medicines reforms

In March this year the TGA finally started rolling out the long awaited Complementary Medicine Reforms. 

 

One of the most significant changes for sponsors of listed complementary medicines is the abolition of the “free text” box for indications.  All listed medicines must now use the permitted indications on offer or apply to add a new permitted indication to the list.  There will be no grandfathering of current claims. No permitted indications will reference prohibited or restricted representations as per the Therapeutic Goods Advertising Code 2015.  For medicines listed prior to 6 March 2018, sponsors must submit a grouping application to remove free text and ensure that only current permitted indications are used. 

 

But it’s not all bad news, there is a 3 year window to update claims and labels –  before TGA starts cancelling products under section 30 – and for the first 18 months (until 6 September 2019) the TGA fees will be waived.

 

On the bright side, this is a great opportunity for Sponsors to clean up their TGA listings and ensure that the evidence to support their indications is current and compliant.

 

If your claim does not fit one of the permitted indications, there is good news for you too!  The TGA have released a new tier of listed medicines – the AUST L(A) –  Assessed Listed Medicines.  To be an assessed listed medicine, the product must comply with the requirements of a listed medicine, but can have intermediate, rather than low level indications.  AUST L(A) products will have all their indications assessed and will be issued with a claimer for the product label stating that it has been assessed by TGA.

 

So, there’s plenty of good news and significant opportunities for sponsors of listed medicines to strengthen claims, consolidate supporting data and ensure a compliant, future focussed product portfolio. If you need help with making the most of this opportunity, contact our expert consultants at [email protected]

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Sponsors struggle with Ministerial discretion

The 2017 Medicines Australia Strategic Agreement with the Australian Government extended the existing five-year anniversary statutory price reduction (SPR) of 5% for F1 medicines and introduced new SPRs for drugs that have been listed for ten years and fifteen years over the five-year term of the agreement (10% and 5%, respectively).

Sponsors were afforded the chance to apply for discretion from the Health Minister to avoid the price cut, based on relevant pricing or clinical factors, with the outcomes for eligible PBS items becoming known on 1 June 2018, when price reductions were implemented.

A Commercial Eyes analysis has identified items that received Ministerial discretion, showing a bleak picture for Sponsors who seek to avoid these newly legislated cuts. Out of 582 items eligible for Ministerial discretion, only 64 were able to avoid a price cut.

Forty-two secured full discretion, with 22 only receiving partial discretion. An overview of these outcomes, and a list of Sponsors receiving discretion for multiple items are presented below.

 

Commercial Eyes has completed a detailed report on Ministerial discretion outcomes, including analysis of the application of Ministerial discretion by:

  • Manufacturer
  • Therapy area
  • PBS Program; and
  • Manner of Administration

The report also includes an analysis of successful outcomes to identify trends and commonalities between items and can be purchased directly from Commercial Eyes. For additional information, or a customised report, contact Matthew Douglas, Market Access Consultant, at [email protected].

 

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The long road to PBS listing for Orkambi

Orkambi (lumacaftor and ivacaftor), a treatment for cystic fibrosis (CF), will go before the PBAC for a fourth time at the upcoming July 2018 PBAC meeting. So far, the road to reimbursement has been filled with multiple rejections, a strong voice from patient advocacy groups, increasing media interest, and the apparent ‘impossible position’ in which both Vertex Pharmaceuticals (the sponsor) and the federal government find themselves.

The sponsor, and patient advocacy organisations, contend that Orkambi is an essential medicine for cystic fibrosis patients that would help limit hospitalisations associated with CF and enhance ability to participate in school, employment, and the community. This view is buoyed by remarks from Health Minister Greg Hunt, who has encouraged Vertex to “give it another go” with the PBAC following an earlier rejection. In commentary from previous submissions, the PBAC supports this view and yet has rejected Orkambi three times “on the basis of unacceptable cost-effectiveness at the requested price and uncertainty around the longer term impact of lumacaftor/ivacaftor on lung function and survival beyond two years of treatment”.

The clinical benefit of Orkambi to cystic fibrosis patients appears to be have been demonstrated and accepted in previous PBAC submissions, with the barrier to recommendation continuing to rest on price, despite repeated proposals for risk-share arrangements and price caps. It is however unclear whether Vertex is seeking a Special Pricing Arrangement.

Recent history has shown that innovative high cost medicines often require multiple trips to the PBAC before being recommended and PBS-listed. Examples include Spinraza (for spinal muscular atrophy), Ibrance and Kisqali (for breast cancer), all requiring multiple submissions prior to recommendation. Celgene’s Otezla (apremilast) has abandoned seeking reimbursement entirely, following seven PBAC rejections.

With its recent stint on Sunrise, Orkambi is a high-profile example of what can occur when both the PBAC and the sponsor are unable to reach agreement on the value of a medicine. Could this evolution of the reimbursement environment extend to current pipeline medicines? Upcoming treatments for migraine might face similar hurdles, as currently available treatments are older, cheaper medicines and the potential patient population is large (equating to high cost to government).

The outcome of July’s meeting may demonstrate that three or four PBAC submissions for innovative high cost drugs has become ‘the new normal’ for gaining reimbursement in Australia.

 

The Commercial Eyes Market Access team has extensive experience in pricing and reimbursement and can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment. Contact us on (03) 9251 0777 to learn more and let us help you envisage, achieve and defend the optimum market access outcomes for your business.

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