On Wednesday 18 March 2015, Medicines
Australia, the peak body representing the innovative pharmaceutical industry in
Australia, published a report on the benchmarking of Australia’s access to new
medicines.
The COMPARE report (a
COMparison of Access and Reimbursement Environments) provides information on
the current state of subsidized access to prescription medicines in Australia
and how we compare to 19 similar OECD countries.
The countries examined were
selected because they have comparable nominal and per capita GDP values to
Australia.
The analysis reviewed 247
new medicines that were first registered in the 20 OECD countries between 1
January 2009 and 30 November 2014.
A copy of the COMPARE report
can be downloaded here https://medicinesaustralia.com.au/wp-content/uploads/sites/52/2015/03/20150331-pub-Compare_Edition1_March2015-FINAL.pdf The
initial version of the report has been revised with minor
updates to Tables 1 & 2. These
changes do not affect Australia’s ranking.
Timely access to new medicines is an important
public health issue. More research is
needed to determine whether this National Medicines Policy objective is currently
being met.1
The COMPARE report is of interest to me given
my long-standing history of conducting research in this area. I have multiple
publications in peer-reviewed journals on this topic that date as far back as
2006.2
A reasonable argument can be made that it is
not necessary to compare access in Australia with as many as 19 other OECD
countries. It is interesting to note
that the OECD countries were selected on the basis of having comparable GDP
values to Australia rather than having comparable health care and/or medicine
reimbursement systems. Some of the 19
OECD countries have private medicine reimbursement systems and/or apply a
different approach to HTA (e.g. “value for money” is not a decision-making
criterion). Canada does not have a
national medicine reimbursement program; the funding of medicines is undertaken
at the provincial level.
Furthermore, it is unreasonable to expect a
medicine first registered in any country on 30 November 2014 to be reimbursed
as at 30 November 2014.
Medicines Australia commissioned IMS Consulting
Group to undertake the analysis. I was
invited by Medicines Australia to submit a proposal for the project in early
December. In the end, I did not submit a
formal proposal, as I was unable to meet some of the requirements.
The Medicines Australia COMPARE report
appears to be a précis of the detailed IMS deliverable, dated 27 February 2015,
which is also available on the Medicines Australia website.
One is unable to check/validate the summary
data on pages 1-7 of the COMPARE report. The first opportunity one has to delve
into the raw data is Table 2 on Page 8. Table
2 has been developed using the data from pages 37-9 of the IMS deliverable.
The COMPARE report states that the data in Table
2 on Page 8 lists the new medicines that have been reimbursed in at least 10 of
the 19 OECD countries but were awaiting reimbursement in Australia as at 30
November 2014. The report notes that
some medicines in the Table 2 have since been listed on the PBS. These medicines have not been identified in
the table by way of an asterisk or similar symbol.
I have attempted to validate the results in
Table 2 using information in the MAESTrO database that was developed from data
in the public domain (in this case, the TGA and PBS websites). My attempt to confirm the results in Table 2
of the COMPARE report is provided in Table A below. Please note that the information in Table A
is current as at 1 April 2015.
Medicine (generic name)
|
Medicine (Australian brand name)
|
Therapeutic area/s
|
Disease/condition*
|
Date of TGA registration (ARTG start date)
|
Orphan drug (Yes/No)
|
Submission considered by PBAC
|
Most recent PBAC outcome
|
Date of most recent PBAC outcome
|
PBS listing status (as at 1 April 2014)
|
Date of PBS listing
|
Belatacept
|
Nulojix
|
Immunology/Nephrology
|
End stage kidney disease/kidney
transplantation
|
15/03/2012
|
No
|
No submission
|
No outcome
|
Not applicable
|
Not listed
|
Not listed
|
Belimumab
|
Benlysta
|
Immunology/Rheumatology
|
Systemic lupus erythematosus
|
Not registered; dossier was rejected
|
No
|
No submission
|
No outcome
|
Not applicable
|
Not listed
|
Not listed
|
Canakinumab
|
Ilaris
|
Immunology/Rheumatology/Paediatrics
|
Cryopyrin associated periodic syndrome
|
10/05/2010
|
Yes
|
No submission
|
No outcome
|
Not applicable
|
Not listed
|
Not listed
|
Pomalidomide
|
Pomalyst
|
Haematology
|
Multiple myeloma
|
1/07/2014
|
Yes
|
Yes
|
Recommendation
|
Nov 2014
|
Not listed
|
Not listed
|
Vilanterol trifenatate with umeclidinium bromide
|
Anoro Ellipta
|
Respiratory disease
|
Chronic obstructive pulmonary disease
|
4/07/2014
|
No
|
Yes
|
Recommendation
|
July 2014
|
Listed
|
1/12/2014
|
Vilanterol trifenatate with umeclidinium bromide
|
Anoro Ellipta
|
Respiratory disease
|
Asthma
|
Not registered for asthma
|
No
|
No submission
|
No outcome
|
Not applicable
|
Not listed
|
Not listed
|
Roflumilast
|
Daxas/Xevex/Dalveza
|
Respiratory disease
|
Chronic obstructive pulmonary disease
|
Not registered; dossier was withdrawn (Nov
2011)
|
No
|
Yes
|
Rejected (submission was considered before
the registration dossier was withdrawn)
|
July 2011
|
Not listed
|
Not listed
|
Ofatumumab acetate
|
Arzerra
|
Haematology
|
Chronic lymphocytic leukaemia1
|
11/02/2013
|
No
|
No submission
|
No outcome
|
Not applicable
|
Listed
|
1/04/2014
|
Trastuzumab emtansine
|
Kadcyla
|
Oncology
|
Breast cancer
|
3/09/2013
|
No
|
Yes
|
Recommendation
|
Late 2014 (out of session meeting)
|
Not listed
|
Not listed
|
Afatinib dimaleate
|
Giotrif
|
Oncology
|
Non-small cell lung cancer
|
7/11/2013
|
No
|
Yes
|
Recommendation
|
Aug 2013 (out of session meeting)
|
Not listed
|
Not listed
|
Axitinib
|
Inlyta
|
Oncology
|
Renal cell carcinoma
|
26/07/2012
|
Yes
|
Yes
|
Recommendation
|
Nov 2014
|
Not listed
|
Not listed
|
Bosutinib monohydrate
|
Bosulif
|
Haematology
|
Chronic myeloid leukaemia
|
29/09/2014
|
Yes
|
No submission
|
No outcome
|
Not applicable
|
Not listed
|
Not listed
|
Crizotinib
|
Xalkori
|
Oncology
|
Non-small cell lung cancer
|
27/09/2013
|
No
|
Yes
|
Recommendation
|
Nov 2014
|
Not listed
|
Not listed
|
Regorafenib monohydrate
|
Stivarga
|
Oncology
|
Colorectal cancer2
|
29/11/2013
|
No
|
Yes
|
Rejection
|
Jul 2014
|
Not listed
|
Not listed
|
Ruxolitinib phosphate
|
Jakavi
|
Haematology
|
Myelofibrosis
|
3/07/2013
|
Yes
|
Yes
|
Unknown
|
Mar 2015
|
Not listed
|
Not listed
|
Vandetanib
|
Caprelsa
|
Oncology
|
Thyroid cancer
|
31/03/2013
|
Yes
|
No submission
|
No outcome
|
Not applicable
|
Not listed
|
Not listed
|
Vemurafenib
|
Zelboraf
|
Oncology
|
Malignant melanoma
|
10/05/2012
|
No
|
Yes
|
Deferral
|
Mar 2013
|
Not listed
|
Not listed
|
Brentuximab vedotin
|
Adcetris
|
Haematology
|
Non-Hodgkin’s lymphoma
|
20/12/2013
|
No
|
Yes
|
Recommendation
|
Jul 2014
|
Yes
|
1/12/2014
|
Eribulin mesylate
|
Halaven
|
Oncology
|
Breast cancer
|
4/09/2012
|
No
|
Yes
|
Recommendation
|
Nov 2013
|
Yes
|
1/10/2014
|
Enzalutamide
|
Xtandi
|
Oncology
|
Prostate cancer
|
1/07/2014
|
No
|
Yes
|
Recommendation
|
Jul 2014
|
Yes
|
1/12/2014
|
Dronedarone hydrochloride
|
Multaq
|
Cardiovascular disease
|
Atrial fibrillation
|
2/08/2010
|
No
|
Yes
|
Rejection
|
Nov 2010
|
Not listed
|
Not listed
|
Riociguat
|
Adempas
|
Cardiovascular disease
|
Pulmonary arterial hypertension
|
14/04/2014
|
Yes
|
Yes
|
Recommendation
|
Mar 2014
|
Not listed
|
Not listed
|
Linagliptin with metformin hydrochloride
|
Trajentamet
|
Endocrinology
|
Type 2 diabetes mellitus
|
21/05/2013
|
No
|
Yes
|
Recommended
|
Early-mid 2013 (out of session meeting)
|
Listed
|
1/03/2014
|
Liraglutide
|
Victoza
|
Endocrinology
|
Type 2 diabetes mellitus
|
26/08/2010
|
No
|
Yes
|
Recommendation
|
Mar 2013
|
Not listed
|
Not listed
|
Lixisenatide
|
Lyxumia
|
Endocrinology
|
Type 2 diabetes mellitus
|
10/04/2013
|
No
|
Yes
|
Rejection
|
Jul 2014
|
Not listed
|
Not listed
|
Fidaxomicin
|
Dificid
|
Infectious disease/Gastroenterology
|
Bacterial infection
|
23/04/2013
|
No
|
No submission
|
No outcome
|
Not applicable
|
Not listed
|
Not listed
|
Collagenase clostridium histolyticum
|
Xiaflex
|
Musculoskeletal
|
Dupuytren’s contracture
|
7/08/2013
|
No
|
Yes
|
Recommendation
|
Jul 2014
|
Not listed
|
Not listed
|
Ingenol mebutate
|
PIcato
|
Dermatology
|
Actinic keratosis
|
9/11/2012
|
No
|
Yes
|
Rejection
|
Jul 2014
|
Not listed
|
Not listed
|
Mirabegron
|
Betmiga
|
Urology
|
Overactive bladder
|
17/10/2013
|
No
|
No submission
|
No outcome
|
Not applicable
|
Not listed
|
Not listed
|
Ceftaroline fosamil acetate monohydrate
|
Zinforo
|
Infectious disease
|
Bacterial infection
|
12/02/2013
|
No
|
No submission
|
No outcome
|
Not applicable
|
Not listed
|
Not listed
|
Simeprevir sodium
|
Olysio
|
Hepatology
|
Hepatitis C
|
18/07/2014
|
No
|
Yes
|
Recommendation
|
Jul 2014
|
Listed
|
1/12/2014
|
Sofosbuvir
|
Sovaldi
|
Hepatology
|
Hepatitis C
|
30/06/2014
|
No
|
Yes
|
Unknown
|
Mar 2015
|
Not listed
|
Not listed
|
Eslicarbazepine acetate
|
Unknown
|
Neurology
|
Epilepsy
|
Not registered
|
No
|
No submission
|
No outcome
|
Not applicable
|
Not listed
|
Not listed
|
Retigabine
|
Trobalt
|
Neurology
|
Epilepsy
|
28/06/2013
|
No
|
No submission
|
No outcome
|
Not applicable
|
Not listed
|
Not listed
|
1 Ofatumumab acetate was first registered by the TGA for later-line
use. It has since been registered by the
TGA for first-line use. The PBAC
considered a submission for first-line use at its meeting in November
2014. Ofatumumab acetate was recommended
by the PBAC and was listed on the PBS on 1 Apr 2014.
2 Regorafenib monohydrate was first registered by the TGA for
patients with colorectal cancer. It has
since been registered by the TGA for patients with a gastro-intestinal stromal
tumour. The PBAC considered a submission
for the new indication at its March 2015 meeting.
One medicine in Table 1 is linagliptin and
metformin hydrochloride (Trajentamet), which was listed on the PBS on 1 March
2014. The inclusion of this combination product in Table 1 is confusing
given it was supposedly excluded from the analysis (Page 80 of IMS deliverable).
My take on Table 2 of the COMPARE
report is provided below in Table B.
Table B – new medicines listed on the PBS in 2014
Month
|
Medicine
|
Disease/condition
|
Sponsor
|
January
|
Nil
|
||
February
|
Nil
|
||
March
|
Nil
|
Nil
|
Nil
|
April
|
Clobetasol propionate (Clobex)
|
Psoriasis
|
Galderma
|
Dolutegravir sodium (Tivicay)
|
HIV infection
|
ViiV
|
|
Glycopyrronium bromide (Seebri Breezhaler)
|
Chronic obstructive pulmonary disease
|
Novartis
|
|
Panitumumab (Vectibix)
|
Colorectal cancer
|
Amgen
|
|
May
|
Sapropterin dihydrochloride (Kuvan)
|
Hyperphenylalaninaemia
|
Merck Serono
|
Plerixafor (Mozobil)
|
Cancer
|
Genzyme
|
|
June
|
Tapentadol hydrochloride (Palexia SR)
|
Pain
|
CSL
|
July
|
Nil
|
||
August
|
Aclidinium bromide (Bretaris Genuair)
|
Chronic obstructive pulmonary disease
|
Menarini
|
Betaine (Cystadane)
|
Homocystinuria
|
Emerge Health
|
|
September
|
Macitentan (Opsumit)
|
Pulmonary arterial hypertension
|
Actelion
|
October
|
Eribulin mesylate (Halaven)
|
Breast cancer
|
Eisai
|
November
|
Perampanel
hemisesquihydrate (Fycompa)
|
Epilepsy
|
Eisai
|
December
|
Brentuximab
vedotin (Adcetris)
|
Non-Hodgkin’s lymphoma
|
Takeda
|
Enzalutamide
(Xtandi)
|
Prostate cancer
|
Astellas
|
|
Ivacaftor
(Kalydeco)
|
Cystic fibrosis
|
Vertex
|
|
Simeprevir
sodium (Olysio)
|
Hepatitis C
|
Janssen-Cilag
|
|
Umeclidinium
bromide (Incruse Ellipta)
|
Chronic obstructive pulmonary disease
|
GSK
|
The COMPARE report is a missed opportunity to
move the much needed debate on Australian patients having timely subsidized
access to new medicines to a better higher level by generating a robust dataset
that provides answers to the key questions.
References
- Australian Government. Department of Health. National Medicines Policy. http://www.health.gov.au/nationalmedicinespolicy
- Wonder MJ, et al. Are Australians able to access new medicines on the Pharmaceutical Benefits Scheme in a more or less timely manner? An analysis of Pharmaceutical Benefits Advisory Committee recommendations 1999-2003. Value Health 2006; 9 (4): 205-12.
