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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 matthew.douglas@commercialeyes.com.au.

 




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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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PBAC Meeting Agenda – July 2018

The July 2018 PBAC Meeting is scheduled from 4 to 6 Jul 2018. Here, the Commercial Eyes Market Access team provides an overview of the meeting agenda, including submissions relating to biosimilars lodged for this meeting.

 

 

The Commercial Eyes Market Access Team 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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PBAC Meeting Outcomes – March 2018

The March 2018 PBAC Meeting Outcomes were published on 20th April 2018. With 71 outcomes in total, the Commercial Eyes Market Access team provides an overview of PBAC decision making, including an additional analysis conducted on oncology submissions which have dominated the meeting.

 

 

The Commercial Eyes Market Access Team 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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PBAC Meeting Agenda – March 2018

 

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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PBAC outcomes: a snapshot of 2017

 

The Commercial Eyes Market Access Team 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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Life Saving Drugs Program: new lease on life, or on life support?

Last week saw the release of the final report of the post-market review into the Life Saving Drugs Program (LSDP), including a response to the report released by the Australian Government. The Life Saving Drugs Program currently provides subsidised access to patients with rare and life-threatening conditions to essential and very expensive medicines. The scheme operates outside the Pharmaceutical Benefits Scheme (PBS), and medicines included often fail to meet the comparative cost-effectiveness criteria required for recommendation and listing on the PBS.

LSDP medicines are provided at no cost to patients. The program includes 13 medications to treat nine diseases, and in 2016-17 assisted 393 patients at a cost of $116 million. Diseases with treatments available include Fabry disease, Gaucher disease, and Hereditary Tyrosinaemia Type I, among others. The LDSP is often home to high-profile, high-cost medicines, such as Soliris® (eculizumab), considered one of the most expensive drugs in the world at $500,000 per patient per year.

The report contains ten recommendations made by an Expert Reference Group formed of clinical experts and chaired by Professor Andrew Wilson (current chair of the Pharmaceutical Benefits Advisory Committee). The Group’s key recommendation is the creation of a new Medicines for Rare Diseases Programme (MRDP), to be incorporated into the PBS (replacing the LSDP). This transition seeks to allow the LSDP to benefit from the existing PBS infrastructure and processes, but also subjects these medicines to PBS pricing mechanisms. Additional recommendations include creating a definition for a ‘rare disease’ for the purposes of the program (proposed to be prevalence of 1 per 50,000 persons), and the retention of the eligibility criteria for access following the transition.

Both the Expert Reference Group (and the Government in its response) agree that the Commonwealth should continue to enable access to medicines for rare diseases, including acknowledgement that they should be evaluated beyond simple cost-effectiveness methods when considering their value. It remains to be seen how well this can be accounted for within the tight financial environment currently in place for PBS-listed medicines.

 

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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What is Happening with the Provisional Approval Pathway?

We’ve come a long way

When the independent review of medicines and medical devices regulation was announced in October 2014, the pharmaceutical sector immediately saw the opportunity for an expediated approval pathway for certain prescription medicines.

A provisional approval pathway would allow certain promising new medicines to reach patients with unmet clinical needs earlier than might otherwise be the case, while ensuring appropriate measures are in place to manage the risks inherent in the fact that additional data are still required. The pathway could allow medicines to reach Australian patients up to two years earlier than under the current framework1. This is similar to pathways now being utilised by the European Medicines Agency (EMA), US Food and Drug Administration (FDA) and Health Canada.

Fast forward to late 2017, and the review has been conducted and reported on, the government has responded to the many recommendations and the Therapeutic Goods Administration (TGA) has managed a huge volume of changes as a result. New or update regulatory processes have been implemented across all product categories and further reform continues.

But where is the much-anticipated Provisional Approval pathway?

Much work has been done by both the regulators and industry to prepare for the introduction of the Provisional Approval pathway to the point where draft guidance has been developed and undergone targeted consultation with relevant industry groups (November 2017).  Advice was that TGA planned for implementation this month (January 2018), or at least in first quarter this year, pending critical legislative changes passing through parliament.

The Therapeutic Goods Amendment (2017 Measures No. 1) 2017 incorporates the necessary legislative changes including creation of a new class of therapeutic goods (‘provisionally registered goods’) on the Australian Register of Therapeutic Goods (ARTG) and new provisions under which medicines eligible for the ‘Provisional Approval’ pathway may then be evaluated for provisional registration.

Also included in the Bill are amendments to the Therapeutic Goods Act facilitating, among other things:

  • Reforms to the regulatory framework for complementary medicines, (including establishing a list of permitted indications and a new assessment pathway for listed complementary medicines);
  • A more comprehensive post-market monitoring scheme;
  • Broadening investigation and enforcement powers;
  • Advertising requirement amendments; and
  • Greater use of assessments of comparable overseas regulators;

It is the slow transition of this Bill through parliament that will push implementation of the provisional Approval pathway out beyond January 2018. On 30 November 2017 the Bill was referred to Senate Community Affairs Legislation Committee for enquiry and report, with the report being due on 2 February 2018.  It is understood that the impetus for referral of the Bill to the Senate Committee came from Greens Senator Richard Di Natale in response to consumer advocate objections to the proposed advertising provisions.

Submissions to the Senate Committee from Medicines Australia and other organisations have urged the Committee to support the proposed reforms including, if required, the separation of the relevant provisional approval provisions into a stand-alone Bill to ensure earliest possible access to promising treatments for Australian patients.  These submissions are consistent with the overall balance of responses which support the majority of the proposed Bill and highlight the advertising reforms as requiring further consideration by the parliament.

What happens next?

For now, we wait with bated breath until the Senate Community Affairs Legislation Committee releases its report on 2 February. It will be the content of that report that determines the immediate fate of the Bill and thus, the Provisional Approval pathway. Possible recommendations include the current Bill is to be passed without amendment or the Bill should be amended (including possible division into two separate Bills).

When the report is available, the Bill will be received by the Senate and continue to follow the standard progress of legislation.  The time taken for the Senate to consider a Bill can vary greatly from a single day, to many months.  Therefore, while the TGA may have established themselves in a good position to launch the new pathway, legislative hurdles still need to be overcome before implementation.

Want to know more?

For further advice on utilising the Provisional Approval pathway please contact our expert Regulatory Services team on +61 3 9251 0777.

https://www.tga.gov.au/sites/default/files/consultation-provisional-approval-pathway-for-prescription-medicines.pdf




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New ‘SmPC’ Format for the Australian Product Information

Australian Product Information

The TGA have published a new form for providing the product information (PI) which means more work for regulatory teams but an enhancement of the quality use of medicines for Australian patients.  The new form will be implemented over a 3-year transition period commencing from 1 January 2018.

The new format is mandatory for all new and changed PIs included in applications submitted after 1 January 2018. It is strongly recommended that reformatted PIs be submitted for Category 1 applications currently under review. All PIs for marketed products will need to be converted to the new format by 31 December 2020.

The new format aligns more closely with the format of the European Summary of Product Characteristics (SmPC) and New Zealand Datasheet although there are some key differences in the presentation of information for the Australian PI for example in sections 4.8 Adverse Effects and 6.7 Physicochemical Properties.

The main change in the form is reordering of the content to increase the prominence of critical clinical information such as indications, dosage and method of administration, contraindications and precautions.  These are now located towards the beginning of the document to further enhance the safe and effective use of medicines.

PIs must be reformatted as part of any application affecting their content but reformatted PIs can also be submitted with other application types which do not include changes to the PI without incurring an additional fee.

The task of reformatting existing PIs may be time consuming initially. The benefits of the new format in the longer term will be realised by the reduction the regulatory burden associated with maintaining Australia texts in alignment with the European SmPC and New Zealand Datasheet.

Sponsors who have undertaken the exercise of reformatting data sheets for New Zealand will appreciate that the process of reformatting product information is quite time consuming, but becomes more efficient with greater familiarisation and experience with the template. Reformatting PIs is an activity that could be done in advance with a view to having reformatted PIs available and ready to incorporate safety, quality or administrative changes as the opportunity arises for submission to the TGA under the appropriate submission category. Bulk reformatting of existing PIs is an activity which is also amenable to outsourcing.

The TGA have provided Frequently asked questions to support the creation of new PIs and reformat of existing PIs. Templates are also available which include the required heading and subheadings. The use of electronic bookmarks is strongly encouraged to facilitate navigation through the document. Important information is also provided for the required clean and annotated versions of the PI which must be submitted to support an application to revise content and reformat the PI.

 

For guidance or assistance in reformatting your PIs contact our expert Regulatory Services team on +61 3 9251 0777.

 




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Commercial Eyes Recruiting: Pharmacovigilance / Drug Safety Professional

Recruiting: Regulatory Services Professional

Commercial Eyes has fabulous new projects coming on line so we are looking for the right people to join our Pharmacovigilance Team.  Working in Commercial Eyes, a leading pharmaceutical consultancy, will give you a breadth of experience across medicines (pharma, OTC), medical devices, and healthcare consumer goods as well as a range of global leading companies. 

 

The Role….

The Pharmacovigilance team are responsible for the day-to-day delivery of pharmacovigilance and safety related projects and services for our clients.  Services, include processing safety information received by, or requiring action on behalf of clients.  Projects include patient safety, support and monitoring programs. All tasks are to be undertaken according to regulatory, Commercial Eyes Pty Ltd and client procedures and Protocols. Responsibilites include;

  • Work within the systems and processes designed to meet Good Pharmacovigilance (GPV) practice.
  • Ensure that all potential adverse events or product complaints are appropriately reported and followed-up according to client procedures.
  • Evaluate adverse events & follow up reports received from various channels and assesses seriousness based on criteria.
  • Process & report safety data as per SOP’s and client instructions in order to maintain client and regulatory compliance.
  • Maintain the integrity of client safety data registered into GxP databases and associated paper based systems.
  • Prepare project reports and tracks agreed KPI’s in order to meet project deliverables.
  • Act as a subject matter expert both internally and externally.
  • Train and mentor other team members.
  • Proactively contribution to improving business processes.
  • Participate in internal and external audits.

 

To be successful in this role, you will ideally possess…..

  • Health Science degree or equivalent
  • At least 12 months’ experience in a drug safety or equivalent role in a highly regulated industry e.g. pharmaceutical or devices (if you are a graduate with less than 12 months we also have some graduate roles so please contact us)
  • Good working knowledge of the regulatory requirements for managing and reporting adverse events in Australia and New Zealand
  • Understanding of the applicable EU requirements
  • Highly developed service, communication, organisational and problem solving skills
  • High level of attention to detail and computer literacy with experience in safety databases
  • Practical experience in SOP writing and document management

 

In return…..

  • Be part of a well-known and established professional services organisation, that has a strong focus on teamwork and that recognises talent and expertise as one of its biggest assets.
  • Expand your network by working with a broad range of local and international industry leading companies developing cutting edge health technologies, across a global landscape.
  • A competitive salary and a flexible work environment, in an environment that respects life-work balance.
  • Interesting and challenging projects to grow and enhance your skills and experience.
  • Be part of a fabulpous team of PV professionals.
  • Fabulous cbd location and offices.

 

To apply, please submit your CV and cover letter to recruitment@commercialeyes.com.au

Please note Commercial Eyes does not accept applications from recruitment agencies.

 

If you are interested in this position or are keen to discuss other possible opportunities at Commercial Eyes please contact Stephanie Gaylard, Human Resources or Lorenza Ricacho Director, Medical Services for a private and confidential discussion on +61392510777.




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